Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019216

FEI Number

3019216

Entity Name

Philips Ultrasound LLC

City/State/Country

BOTHELL, WA, US

Establishment Address

22100 Bothell Everett Hwy, BOTHELL, WA 98021, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Philips Medical Systems International BV (Owner Number: 1217116)

Owner / Operator Contact Address

Veenpluis 6, Best, NL-NOTA 5684PC, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233545

PMA Number

N/A

All Registered Proprietary Names

EPIQ Elite Diamond Select Ultrasound System; EPIQ CVx Diamond Select Ultrasound System; EPIQ CVx Diagnostic Ultrasound System; EPIQ 7W Diagnostic Ultrasound System; EPIQ 5 Circular Edition Ultrasound System; EPIQ Elite Circular Edition Ultrasound System; EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; EPIQ Diagnostic Ultrasound System; EPIQ 7C Diagnostic Ultrasound System; EPIQ 7G Diagnostic Ultrasound System; EPIQ 5C Diagnostic Ultrasound System; EPIQ 7 Diamond Select Ultrasound System; EPIQ CVxi Diagnostic Ultrasound System; EPIQ 5G Diagnostic Ultrasound System; EPIQ 5 Diamond Select Ultrasound System; EPIQ 5W Diagnostic Ultrasound System; EPIQ 7 Circular Edition Ultrasound System; EPIQ Elite W Diagnostic Ultrasound System; EPIQ Elite Diagnostic Ultrasound System; EPIQ CVx Circular Edition Ultrasound System; Collaboration Live L12-5 iU22 Ultrasound System PercuNav EPIQ 5G Diagnostic Ultrasound System D2tcd S8-3t C6-2 X7-2t EPIQ Elite W Diagnostic Ultrasound System Affiniti 70W Diagnostic Ultrasound System S12-4 S9-2 S5-1 C5-1 VL13-5 L12-3 ERGO EPIQ Diagnostic Ultrasound System EPIQ 7G Diagnostic Ultrasound System EPIQ 7C Diagnostic Ultrasound System EPIQ 7W Diagnostic Ultrasound System BP10-5ec L12-4 Affiniti 70C Diagnostic Ultrasound System 3D9-3v D2cwc X8-2t XL14-3 L18-5 C8-5 Affiniti 70 Diagnostic Ultrasound System Affiniti 50W Diagnostic Ultrasound System EPIQ CVxi Diagnostic Ultrasound System S7-3t D5cwc EPIQ 5 Diagnostic Ultrasound System X7-2 Affiniti 50G Diagnostic Ultrasound System V6-2 eL18-4 L12-5 50 mC7-2 Affiniti 50C Diagnostic Ultrasound System Affiniti 50 Diagnostic Ultrasound System X8-2ti EPIQ 7 Diagnostic Ultrasound System C9-2 C9-4v S4-2 L15-7io X5-1 C10-4ec V9-2 L12-3 S8-3 EPIQ CVx Diagnostic Ultrasound System EPIQ 5C Diagnostic Ultrasound System EPIQ 5W Diagnostic Ultrasound System X6-1 EPIQ Elite Diagnostic Ultrasound System Affiniti 70G Diagnostic Ultrasound System C10-3v X5-1c Lumify Diagnostic Ultrasound System Affiniti Series Diagnostic Ultrasound System EPIQ Series Diagnostic Ultrasound System EPIQ CVxi Ultrasound System EPIQ 7 Ultrasound System Affiniti 30 Ultrasound System Affiniti 70 Diamond Select Ultrasound System EPIQ 5W Ultrasound System Affiniti 50 Ultrasound System EPIQ Elite Diagnostic Ultrasound System EPIQ 5 Diamond Select Ultrasound System EPIQ Series Diagnostic Ultrasound System Affiniti 70 Ultrasound System EPIQ CVx Ultrasound System Affiniti Series Diagnostic Ultrasound System Affiniti 50 Diamond Select Ultrasound System EPIQ 5 Ultrasound System Affiniti CVx Ultrasound System Affiniti 30 Diamond Select Ultrasound System EPIQ 7 Diamond Select Ultrasound System EPIQ CVx Circular Edition Ultrasound System EPIQ 7W Ultrasound System EPIQ 7 Circular Edition Ultrasound System EPIQ 5 Circular Edition Ultrasound System Affiniti 70 Circular Edition Ultrasound System EPIQ Elite Circular Edition Ultrasound System Affiniti 30 Circular Edition Ultrasound System Affiniti 50 Circular Edition Ultrasound System QLAB Advanced Quantification Software X3-1 S5-1 iE33 Diagnostic Ultrasound System iU22 Diagnostic Ultrasound System Philips ultrasound probe 8V3A Sector Transducer 12L5A Linear Array Transducer 8EC4A Curved Array Transducer 9MC3 Curved Array Transducer 5C2A Curved Linear Array Transducer 4V2A Sector Transducer HDI 5000 Diagnostic Ultrasound System L12-5 38mm L12-5 50mm C5-1 iU22 Diagnostic Ultrasound System Affiniti 70G Diagnostic Ultrasound System V6-2 C10-3v S8-3 L18-5 C10-4ec S8-3t Affiniti 50C Diagnostic Ultrasound System D5cwc L15-7io EPIQ 5C Diagnostic Ultrasound System S12-4 S5-1 L12-4 L12-5 50 L12-3 Affiniti 70W Diagnostic Ultrasound System EPIQ 7G Diagnostic Ultrasound System BP10-5ec C9-4v D2cwc S9-2 C5-1 X8-2ti D2tcd EPIQ 5 Diagnostic Ultrasound System eL18-4 EPIQ 5W Diagnostic Ultrasound System C8-5 VL13-5 Affiniti 50G Diagnostic Ultrasound System X5-1 EPIQ CVx Diagnostic Ultrasound System S7-3t Affiniti 50W Diagnostic Ultrasound System 3D9-3v X8-2t C6-2 Affiniti 70 Diagnostic Ultrasound System X7-2t EPIQ 7W Diagnostic Ultrasound System EPIQ 7 Diagnostic Ultrasound System Affiniti 70C Diagnostic Ultrasound System XL14-3 X6-1 EPIQ CVxi Diagnostic Ultrasound System EPIQ 5G Diagnostic Ultrasound System X7-2 S4-2 EPIQ 7C Diagnostic Ultrasound System EPIQ Diagnostic Ultrasound System C9-2 Affiniti 50 Diagnostic Ultrasound System Lumify Diagnostic Ultrasound System Lumify Diamond Select Diagnostic Ultrasound System Lumify Circular Edition Diagnostic Ultrasound System Lumify Diagnostic Ultrasound System Ultrasound System 5500W 5000 Compact Series Ultrasound Systems Ultrasound System 5500P Premium Compact Cart Ultrasound System 5500G Ultrasound System 5500CV Ultrasound System 5300P Extended Compact Cart Ultrasound System 5300W Deluxe Compact Cart Ultrasound System 5300G EPIQ 7G Diagnostic Ultrasound System EPIQ Diagnostic Ultrasound System EPIQ 7 Diagnostic Ultrasound System EPIQ 5C Diagnostic Ultrasound System V6-2; V9-2; VL13-5 eL18-4; eL18-4 EMT L12-3; L12-3ERGO D2tcd; D5cwc L12-5; L15-7io; L18-5 S4-2; S5-1 EPIQ Elite Diagnostic Ultrasound System C10-4ec; D2cwc EPIQ CVx Diagnostic Ultrasound System EPIQ 7W Diagnostic Ultrasound System EPIQ 7C Diagnostic Ultrasound System X5-1; X6-1; X7-2; X7-2t ; X8-2t; XL14-3 S7-3t; S8-3;S8-3t; S9-2 EPIQ 5G Diagnostic Ultrasound System EPIQ 5W Diagnostic Ultrasound System mC7-2; mC12-3 C5-1; C6-2; C8-5; C9-2; C10-3v EPIQ CVxi Diagnostic Ultrasound System 3D9-3v EPIQ 5 Diagnostic Ultrasound System L15-7io C8-5 Affiniti 70 Diagnostic Ultrasound System D2tcd X5-1 S12-4 Affiniti 50W Diagnostic Ultrasound System C9-4v Affiniti 70G Diagnostic Ultrasound System eL18-4 X8-2ti X14-3 C10-3v C6-2 D5cwc Affiniti 70C Diagnostic Ultrasound System L12-3 X7-2t Affiniti 50G Diagnostic Ultrasound System Affiniti 50 Diagnostic Ultrasound System S8-3 C5-1 C9-2 X6-1 EPIQ 5G Diagnostic Ultrasound System X7-2 V6-2 D2cwc S4-2 EPIQ 5 Diagnostic Ultrasound System S8-3t S7-3t EPIQ 7 Diagnostic Ultrasound System VL13-5 Affiniti 70W Diagnostic Ultrasound System L18-5 EPIQ 5C Diagnostic Ultrasound System 3D9-3v EPIQ 7W Diagnostic Ultrasound System EPIQ 7G Diagnostic Ultrasound System X8-2t S5-1 C10-4ec Affiniti 50C Diagnostic Ultrasound System EPIQ Diagnostic Ultrasound System L12-5 50 EPIQ 5W Diagnostic Ultrasound System L12-4 EPIQ 7C Diagnostic Ultrasound System BP10-5ec TOMTEC-ARENA TomTec-Arena HD11 Diagnostic Ultrasound System BP10-5ec V6-2 C6-3 V8-4 L9-3 EPIQ Series Diagnostic Ultrasound Systems HD9 Ultrasound System & Transducers Lumify Ultrasound System C5-2 L12-4 Affiniti Series Diagnostic Ultrasound System Epiq Series Diagnostic Ultrasound System Lumify 5.2 (Lung APP-3) C9-4v Affiniti 50 Diagnostic Ultrasound System C8-5 D5cwc S7-3t Affiniti 70 Diagnostic Ultrasound System C10-3v S5-1 V6-2 EPIQ 5 Diagnostic Ultrasound System X7-2 L15-7io VL13-5 L18-5 X5-1 EPIQ 7 Diagnostic Ultrasound System 3D9-3v BP10-5ec L12-4 C6-2 L12-5 50 C5-1 S8-3 S4-2 C10-4ec X6-1 D2cwc L12-3 X7-2t D2tcd C9-2 S12-4 C8-4v 3D6-2 C5-2 S4-1 L12-4 Lumify Ultrasound System V6-2 S4-1 ClearVue 550 Diagnostic Ultrasound System ClearVue 650 Diagnostic Ultrasound System ClearVue 350 Diagnostic Ultrasound System L12-4 3D9-3v C5-2 ClearVue 580 Diagnostic Ultrasound System C9-4v EPIQ 7 Ultrasound System EPIQ CVx Ultrasound System EPIQ 7 Diamond Select Ultrasound System EPIQ 7W Ultrasound System EPIQ Elite Diagnostic Ultrasound System EPIQ 5 Ultrasound System EPIQ Series Diagnostic Ultrasound System Transducer mL26-8 EPIQ 7 Circular Edition Ultrasound System EPIQ 5 Diamond Select Ultrasound System EPIQ CVx Circular Edition Ultrasound System EPIQ CVxi Ultrasound System EPIQ 5 Circular Edition Ultrasound System EPIQ 5W Ultrasound System EPIQ Elite Circular Edition Ultrasound System InnoSight Diagnostic Ultrasound System Transducers: S4-2, C9-4v, L12-4, C6-2 Collaboration Live S5-1 D2cwc CX50 Diagnostic Ultrasound System X7-2t Q-Station Xperius Ultrasound System S5-1 X7-2t S4-2 C9-4v CX50 Diagnostic Ultrasound System Sparq Diagnostic Ultrasound System L12-4 C6-2 C5-1 C9-3v D5cwc L12-3 D5cwc CX50 Diagnostic Ultrasound System D2cwc L12-5 50 C6-2 S8-3 S4-2 S7-3t C10-3v S5-1 C9-4v L10-4lap C8-5 L12-3 L12-4 C9-3io C9-3v X7-2t L15-7io Sparq Diagnostic Ultrasound System C5-1 S12-4 CX50 Diamond Select Diagnostic Ultrasound System Sparq Diamond Select Diagnostic Ultrasound System CX50 Circular Edition Diagnostic Ultrasound System Sparq Circular Edition Diagnostic Ultrasound System 3D9-3v X6-1 X5-1 Affiniti 70W Diagnostic Ultrasound System V6-2 Affiniti 70G Diagnostic Ultrasound System EPIQ 5C Diagnostic Ultrasound System D2tcd D5cwc C9-2 C6-2 S4-2 EPIQ 7 Diagnostic Ultrasound System C8-5 EPIQ 5 Diagnostic Ultrasound System S8-3 X8-2t X7-2t L12-4 C10-4ec Affiniti 50C Diagnostic Ultrasound System S8-3t C5-1 Affiniti 50 Diagnostic Ultrasound System Affiniti 70C Diagnostic Ultrasound System EPIQ 7C Diagnostic Ultrasound System D2cwc S5-1 Affiniti 50G Diagnostic Ultrasound System L15-7io Affiniti 70 Diagnostic Ultrasound System VL13-5 EPIQ 5W Diagnostic Ultrasound System L18-5 S7-3t EPIQ 7G Diagnostic Ultrasound System X7-2 BP10-5ec Affiniti 50W Diagnostic Ultrasound System S12-4 C10-3v EPIQ 7W Diagnostic Ultrasound System L12-3 L12-5 50 C9-4v EPIQ 5G Diagnostic Ultrasound System EPIQ 5 Diagnostic Ultrasound System EPIQ Elite Diamond Select Ultrasound System Affiniti 50C Diagnostic Ultrasound System EPIQ 5 Diamond Select Ultrasound System Affiniti 50W Diagnostic Ultrasound System EPIQ 7 Diagnostic Ultrasound System EPIQ 5 Circular Edition Ultrasound System Affiniti 50 Diamond Select Ultrasound System Affiniti 30 Circular Edition Ultrasound System EPIQ Elite W Diagnostic Ultrasound System Affiniti CVx Ultrasound System Affiniti 70 Diagnostic Ultrasound System EPIQ 7 Diamond Select Ultrasound System EPIQ 7W Diagnostic Ultrasound System EPIQ Elite Circular Edition Ultrasound System EPIQ 7G Diagnostic Ultrasound System Affiniti Series Diagnostic Ultrasound System Affiniti 50 Diagnostic Ultrasound System EPIQ Diagnostic Ultrasound System EPIQ 5G Diagnostic Ultrasound System EPIQ CVx Circular Edition Ultrasound System EPIQ 5C Diagnostic Ultrasound System EPIQ CVx Diagnostic Ultrasound System Affiniti 70 Circular Edition Ultrasound System Affiniti 70G Diagnostic Ultrasound System Affiniti 30 Diamond Select Ultrasound System Affiniti 50G Diagnostic Ultrasound System Affiniti CVx Circular Edition Ultrasound System Affiniti 50 Circular Edition Ultrasound System EPIQ CVx Diamond Select Ultrasound System EPIQ CVxi Diagnostic Ultrasound System EPIQ Elite Diagnostic Ultrasound System EPIQ 7 Circular Edition Ultrasound System EPIQ 5W Diagnostic Ultrasound System Affiniti 70 Diamond Select Ultrasound System EPIQ 7C Diagnostic Ultrasound System Affiniti 70C Diagnostic Ultrasound System Affiniti 70W Diagnostic Ultrasound System PercuNav Image Fusion and Interventional Navigation System Ultrasound Workspace Affiniti Series Diagnostic Ultrasound System Epiq Series Diagnostic Ultrasound System C9-4ec Transducer Lumify Diagnostic Ultrasound System VISIQ Diagnostic Ultrasound System C5-2 EPIQ 5W Ultrasound System Affiniti 50 Diamond Select Ultrasound System Affiniti CVx Ultrasound System EPIQ 7 Ultrasound System EPIQ 7W Ultrasound System EPIQ 5 Diamond Select Ultrasound System Affiniti 50 Ultrasound System Affiniti 30 Diamond Select Ultrasound System Affiniti 30 Ultrasound System EPIQ CVx Ultrasound System Affiniti 70 Ultrasound System EPIQ 7 Diamond Select Ultrasound System EPIQ CVxi Ultrasound System EPIQ CVx Circular Edition Ultrasound System EPIQ Elite Diagnostic Ultrasound System EPIQ 5 Ultrasound System Affiniti 70 Diamond Select Ultrasound System EPIQ Elite Circular Edition Ultrasound System Affiniti 70 Circular Edition Ultrasound System EPIQ 5 Circular Edition Ultrasound System EPIQ 7 Circular Edition Ultrasound System Affiniti 30 Circular Edition Ultrasound System Affiniti 50 Circular Edition Ultrasound System EPIQ Series Diagnostic Ultrasound System Affiniti Series Diagnostic Ultrasound System QLAB Advanced Quantification Software EPIQ 5 Diamond Select Ultrasound System Affiniti CVx Ultrasound System EPIQ CVxi Ultrasound System Affiniti 50 Diamond Select Ultrasound System EPIQ 7 Diamond Select Ultrasound System EPIQ 5W Ultrasound System EPIQ Elite Diagnostic Ultrasound System Affiniti 30 Diamond Select Ultrasound System EPIQ 7W Ultrasound System Affiniti 30 Ultrasound System Affiniti 50 Ultrasound System EPIQ 5 Ultrasound System EPIQ 7 Ultrasound System Affiniti 70 Ultrasound System EPIQ CVx Ultrasound System Affiniti 70 Diamond Select Ultrasound System Affiniti 50 Circular Edition Ultrasound System EPIQ CVx Circular Edition Ultrasound System Affiniti 30 Circular Edition Ultrasound System Affiniti 70 Circular Edition Ultrasound System EPIQ 5 Circular Edition Ultrasound System EPIQ 7 Circular Edition Ultrasound System EPIQ Elite Circular Edition Ultrasound System S4-2 EPIQ 7 Diagnostic Ultrasound System S8-3 C9-2 BP10-5ec X7-2 C6-2 S5-1 L12-4 S12-4 EPIQ 5 Diagnostic Ultrasound System C9-4v L18-5 X5-1 Affiniti 50 Diagnostic Ultrasound System L12-5 50 D2tcd X6-1 X7-2t Affiniti 70 Diagnostic Ultrasound System 3D9-3v S7-3t D5cwc C10-3v C8-5 VL13-5 V6-2 C10-4ec Affiniti 30 Diagnostic Ultrasound System L12-3 D2cwc C5-1 L15-7io S5-1 C5-1 X7-2t L12-3 C9-3v D5cwc CX50 Diagnostic Ultrasound System D2cwc PercuNav Coaxial Needle Tracker, 13Gx16cm PercuNav Coaxial Needle Tracker, 13Gx11cm PercuNav Coaxial Needle Tracker, 20Gx13cm PercuNav Patient Tracker PercuNav Ultrasound Tracker PercuNav Coaxial Needle Tracker, 20Gx17cm PercuNav Coaxial Needle Tracker, 18Gx8cm Adaptive Needle Tracker PercuNav Endocavity Ultrasound Tracker PercuNav Coaxial Needle Tracker, 18Gx13cm PercuNav Coaxial Needle Tracker, 17Gx16cm PercuNav Coaxial Needle Tracker, 16Gx11cm PercuNav Coaxial Needle Tracker, 20Gx8cm PercuNav Image Fusion and Interventional Navigation TOMTEC-ARENA S5-2 D2cwc HD15 Diagnostic Ultrasound System S12-4 S7-2omnni D5cwc V6-2 L15-7io L9-3 3D9-3v L12-5 L12-3 C5-2 C8-4v S8-3 C8-5 BP10-5ec C6-3 IntelliSpace PACS Anywhere FetView OBGYN Cloud Reporting QLAB Advanced Quantification Software Affiniti Series Diagnostic Ultrasound System EPIQ Series Diagnostic Ultrasound System Ultrasound System 5500CV Ultrasound System 5300P Ultrasound System 5500P Ultrasound System 5300W Ultrasound System 5500G Ultrasound System Ultrasound System 5300G Ultrasound System 5500W 5C2A Curved Linear Array Transducer 8V3A Sector Transducer 8EC4A Curved Array Transducer 12L5A Linear Array Transduce 4V2A Sector Transducer C9-4ec C8-4v 21373B (C5040) EnVisor Diagnostic Ultrasound System 21350A (S8) C6-3 21475A 21369A (Omni II) 21221B (C1914C) 21330A (S4) 21359A (L7535) 21321A (C3540) C5-2 21390A (15-61) 21223B (D5014V) 21380A (S12) 21422A 21360A (L5035) 21228B (D1914V) S4-2 C8-5 S4 Affiniti Series Diagnostic Ultrasound System EPIQ Series Diagnostic Ultrasound System EPIQ CVx Diagnostic Ultrasound System EPIQ Elite Diagnostic Ultrasound System EPIQ 7W Diagnostic Ultrasound System Affiniti 70 Circular Edition Ultrasound System EPIQ 7G Diagnostic Ultrasound System EPIQ 5 Circular Edition Ultrasound System EPIQ 5 Diamond Select Ultrasound System Affiniti 50G Diagnostic Ultrasound System Affiniti 50 Diagnostic Ultrasound System Affiniti Series Diagnostic Ultrasound System EPIQ 5W Diagnostic Ultrasound System EPIQ Elite W Diagnostic Ultrasound System Affiniti 30 Diamond Select Ultrasound System Affiniti CVx Ultrasound System EPIQ 7 Circular Edition Ultrasound System EPIQ 7C Diagnostic Ultrasound System Affiniti 70 Diamond Select Ultrasound System EPIQ Elite Circular Edition Ultrasound System Affiniti 50 Diamond Select Ultrasound System Affiniti 50W Diagnostic Ultrasound System EPIQ Diagnostic Ultrasound System EPIQ 5 Diagnostic Ultrasound System Affiniti 70 Diagnostic Ultrasound System Affiniti 50C Diagnostic Ultrasound System Affiniti 70G Diagnostic Ultrasound System EPIQ 7 Diamond Select Ultrasound System EPIQ CVx Diamond Select Ultrasound System EPIQ Elite Diamond Select Ultrasound System Affiniti 70C Diagnostic Ultrasound System EPIQ CVx Circular Edition Ultrasound System EPIQ CVxi Diagnostic Ultrasound System Affiniti 50 Circular Edition Ultrasound System Affiniti 30 Circular Edition Ultrasound System EPIQ 7 Diagnostic Ultrasound System EPIQ 5G Diagnostic Ultrasound System EPIQ 5C Diagnostic Ultrasound System Affiniti 70W Diagnostic Ultrasound System Flash Ultrasound System 5100 Point of Care Lumify Diagnostic Ultrasound System QLAB Advanced Quantification Software S3 LVivo View Selection LVivo Seamless Image-Arena 4.5, Echo-Com 4.5, Image-Com 4.5 Image-Arena and Image-Arena Applications EPIQ Diagnostic Ultrasound Systems QLAB Advanced Quantification Software Affiniti Diagnostic Ultrasound Systems Cx50 Diagnostic Ultrasound System Sparq Diagnostic Ultrasound System Lumify Diagnostic Ultrasound System EPIQ Circular Edition Diagnostic Ultrasound System Affiniti Circular Edition Diagnostic Ultrasound System Sparq Circular Edition Diagnostic Ultrasound System CX50 Circular Edition Diagnostic Ultrasound System Lumify Circular Edition Diagnostic Ultrasound System CX50 Diamond Select Diagnostic Ultrasound System Sparq Diamond Select Diagnostic Ultrasound System Lumify Diamond Select Diagnostic Ultrasound System EPIQ CVxi Diagnostic Ultrasound System EPIQ CVx Diamond Select Ultrasound System EPIQ Elite W Diagnostic Ultrasound System EPIQ 5W Diagnostic Ultrasound System EPIQ 7C Diagnostic Ultrasound System EPIQ CVx Diagnostic Ultrasound System EPIQ 5 Circular Edition Ultrasound System EPIQ 7 Circular Edition Ultrasound System EPIQ Elite Diagnostic Ultrasound System EPIQ 7 Diagnostic Ultrasound System EPIQ 7G Diagnostic Ultrasound System EPIQ 7W Diagnostic Ultrasound System Transducer X11-4t EPIQ CVx Circular Edition Ultrasound System EPIQ 5 Diagnostic Ultrasound System EPIQ 7 Diamond Select Ultrasound System EPIQ Elite Diamond Select Ultrasound System EPIQ Diagnostic Ultrasound System EPIQ 5C Diagnostic Ultrasound System EPIQ 5 Diamond Select Ultrasound System EPIQ Elite Circular Edition Ultrasound System EPIQ 5G Diagnostic Ultrasound System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-11-05
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-11-05
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2024-11-05
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2024-11-05
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-11-05
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2020-09-22
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-09-22
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-09-22
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2010-02-22
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2010-02-22
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2010-02-22
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2013-11-18
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2013-11-18
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-11-18
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-11-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-11-13
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-11-13
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-02-20
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-02-20
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-02-20
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2024-02-20
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2025-06-23
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-06-23
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-06-23
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2025-06-23
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-06-23
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2021-09-20
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-09-20
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2021-09-20
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-09-20
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-09-20
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-06-24
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2000-07-17
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2000-07-17
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2000-07-17
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-05-26
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-05-26
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-05-26
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2009-02-09
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2015-01-27
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2015-01-27
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2015-01-27
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-07-31
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-07-31
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-07-31
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-02-25
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-02-25
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-02-25
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-02-20
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2024-02-20
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-02-20
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-02-20
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2022-10-14
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-10-14
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2022-10-14
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-03-10
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-03-10
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-03-10
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-10-05
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2017-10-05
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-10-05
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2020-10-19
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2020-10-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-12-07
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2009-02-09
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2009-02-09
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2009-02-09
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-09-04
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-09-04
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-09-04
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2020-09-04
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2009-02-09
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2009-02-09
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2009-02-09
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2015-11-02
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2015-11-02
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2015-11-02
POK	Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer	Radiology	Class 2	892.2060	2026-06-09
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2026-06-09
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2026-06-09
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2026-06-09
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2026-06-09
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2026-06-09
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2026-01-13
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2026-01-13
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2026-01-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2026-01-13
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2013-08-27
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2013-08-27
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2013-08-27
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	1992-11-19
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	1992-11-19
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	1992-11-19
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-10-14
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-10-14
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-10-14
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2012-02-28
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2012-02-28
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2012-02-28
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2023-05-15
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-05-15
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2023-05-15
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-05-15
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-05-15
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-12-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2020-03-10
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-03-10
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-03-10
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2009-02-09
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2009-02-09
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2009-02-09
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2014-07-29
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-12-05
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-12-05
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-12-05
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2011-08-11
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2011-08-11
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2011-08-11
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-09-22
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-09-22
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-09-22
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-01-13
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2017-01-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-01-13
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2024-04-26
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-04-26
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2024-04-26
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-04-26
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-04-26
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2023-01-20
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-01-20
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-01-20
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-03-19
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2025-03-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2025-03-19
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2026-04-29
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2026-04-29
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2026-04-29
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2026-04-29
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2026-04-29
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-06-09
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-06-09
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-06-09
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2014-07-28
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2014-07-28
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2014-07-28
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2021-09-27
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-09-27
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-09-27
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-05-07
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2025-05-07
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-05-07
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-05-07
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2025-05-07
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-06-08
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-09-27
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-09-27
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2021-09-27
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2021-09-27
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-09-27
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-04-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-04-13
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-04-13
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2011-08-10
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2011-08-10
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2011-08-10
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2017-05-02
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-05-02
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2017-05-02
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2022-01-19
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2022-01-19
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2009-02-09
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2009-02-09
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2009-02-09
LMD	System, Digital Image Communications, Radiological	Radiology	Class 1	892.2020	2006-02-21
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2020-07-29
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2025-06-23
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-06-23
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2025-06-23
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-06-23
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-06-23
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-12-19
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2024-12-19
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-12-19
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-12-19
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-05-26
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-05-26
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-05-26
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	1995-07-11
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	1995-07-11
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	1995-07-11
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2025-07-29
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-07-29
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-07-29
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-07-29
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2025-07-29
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-03-25
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-03-25
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2024-03-25
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2024-03-25
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-03-25
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-05-16
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-05-16
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-05-16
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-06-09
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-06-09
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-06-09
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2017-05-31
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2009-02-09
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2009-02-09
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2009-02-09
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2025-08-15
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2017-12-19
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-05-20
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2020-05-20
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-05-20
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-05-20
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-03-25
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-03-25
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-03-25

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Philips Medical Systems International BV

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3038281851	Philips Polska Sp. z o.o.	Lodz Lodzkie, PL
3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
3042175841	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Best Noord-Brabant, NL
3008514395	Telcare, LLC	Linwood, PA, US
3004961434	RESPIRATORY TECHNOLOGIES, INC.	Plymouth, MN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K882805	Coopervision-Cilco	CILCO VILLASENOR PACHYMETER	1988-08-12
K791040	Shimadzu Corp.	SECTOR SCANNER, SDU-100, COMPUTERIZED	1979-10-04
K162372	Qt Ultrasound, LLC	QT Ultrasound Breast Scanner-1	2017-06-06
K930964	Acuson Corp.	ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE)	1994-10-26
K052355	U-Systems, Inc.	AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS	2005-09-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2011	Verathon, Inc.	2	BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.
Z-0004-2011	Verathon, Inc.	2	AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements
Z-0005-2011	Verathon, Inc.	2	BladderScan BVM 9500 The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively.
Z-0027-2014	SonoSite, Inc.	2	P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler.
Z-0009-2022	DJO, LLC	2	GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD, 2791/ INTELECT LEGEND XT COMBO US STD W/CART, 2782-10/ INTELECT TRANSPORT US STD, 2782-2/ INTELECT TRANSPORT US STD, 2843/ INTELECT VET 4CH COMBO PKG, 2845K/ KIT INTELECT VET 4CH COMBO PKG, 2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM, 2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL, 2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL, 2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD, 2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL, 2792/ VECTRA GENISYS 2CH COMBO US STD W/CART, 2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL, 2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL, 2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL, 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL, 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL, 2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL, 2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART, 2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL, 2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL, 2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL, 2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL, 2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL, 2796/ VECTRA GENISYS 4CH COMBO US STD W/CART, 2796K/ KIT VECTRA GENISYS 4CH COMBO P, 2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL, 2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL, 2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL, 2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL, 2738/ INTELECT TRANSPORT COMBO PKG US STD, 8250KP/ KIT TRITON DTS PROMO, 6001/ INTELECT NEO, 2738-10/ INTELECT TRANSPORT COMBO PKG US STD, 2738-2/ INTELECT TRANSPORT COMBO PKG US STD, 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD, 2776/ INTELECT MOBILE INT'L STD 5CM APPL, 27800/ ULTRASOUND ON CART, 2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL, 2776-10/ INT MOBIL INT'L STD 10CM APPL, 2776-2/ INT MOBILE INT'L STD 2CM APPL, 2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL, 2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL, 2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL, 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD, 2756/ INTELECT VET 2CH COMBO PKG INT'L STD, 2844K/ KIT INTELECT VET 2CH COMBO PKG, 2782/ INTELECT TRANSPORT US STD, 2895K/ KIT CART ADAPT BL W/CT/SPEC US, 2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD, 2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART, 2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD, 2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART, 7550/ INT LEGEND COMBO 4C US STD, INT001/ INTELECT LEGEND ULTRASOUND US STD, INTC B/ INT CB PKGD US STD, 39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO, 39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO, 13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES, 15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG, 15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS, 15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG, 15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS, 2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG, 2174KIT/ INTELECT RPW 2 230V KIT EU PLUG, 2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG, 2176KIT/ INTELECT RPW 2 120V USA KIT, 12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD, 2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD, 70002/ NEO MODULE ULTRASOUND

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019216. Last updated year: 2026. Please use registration number 3019216 when referencing this establishment in official correspondence.