Philips Ultrasound LLC

FDA Device Registration & Listing · Cambridge, MA, US · Registration 3017894900

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3017894900
FEI Number
3017894900
Entity Name
Philips Ultrasound LLC
City/State/Country
Cambridge, MA, US
Establishment Address
222 Jacobs Street, Cambridge, MA 02141, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Philips Medical Systems International BV (Owner Number: 1217116)
Owner / Operator Contact Address
Veenpluis 6, Best, NL-NOTA 5684PC, NL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K141369
PMA Number
N/A

All Registered Proprietary Names

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 Lumify 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 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 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 PercuNav Image Fusion And Interventional Navigation Xperius Ultrasound System L12-4 S4-1 Lumify Diagnostic Ultrasound System iOS C5-2 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 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 D2cwc L15-7io 3D8-4 C5-2 (21426A) S4-2 HD11 Diagnostic Ultrasound System C8-5 S8-3 (21750A) S7-2omni (21778A) L12-3 C9-5ec L8-4 L12-5 D5cwc 3D6-2 D2tcd 3D9-3v PA4-2 (21422A) C9-4 T6H (21378A) S7-3t (21781A) S3-1 (21711A) S12-4 (21780A) C8-4 (21437A) Collaboration Live 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 HDI 5000 Diagnostic Ultrasound System L12-5 38mm L12-5 50mm Q-Station PercuNav Image Fusion and Interventional Navigation 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 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 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 ClearVue 350 Diagnostic Ultrasound System ClearVue 650 Diagnostic Ultrasound System ClearVue 550 Diagnostic Ultrasound System ClearVue 850 Diagnostic Ultrasound System HD9 Ultrasound System & Transducers Lumify Diagnostic Ultrasound System Lumify Diamond Select Diagnostic Ultrasound System Lumify Circular Edition Diagnostic Ultrasound System C6-2 C5-1 C9-3v S5-1 CX30 Diagnostic Ultrasound System L15-7io C10-3v CX50 Diagnostic Ultrasound System S8-3 D5cwc D2cwc S12-4 L12-5 50 C9-4v C9-3io S4-2 X7-2t C8-5 L12-3 LAP L9-5 L12-4 QLAB Advanced Quantification Software Collaboration Live AAA Model EPIQ Series Diagnostic Ultrasound Systems 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 Lumify 5.2 (Lung APP-3) PercuNav Lumify Ultrasound System C5-2 L12-4 QLAB Advanced Quantification Software 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 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 C5-2 S4-1 L12-4 Lumify Ultrasound System 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 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 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 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 C9-4ec Transducer Lumify Diagnostic Ultrasound System S5-1 D2cwc CX50 Diagnostic Ultrasound System X7-2t L12-5 iU22 Ultrasound System HD11 Diagnostic Ultrasound System BP10-5ec V6-2 C6-3 V8-4 L9-3 S3 VISIQ Diagnostic Ultrasound System C5-2

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
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
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
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
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
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
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
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2020-05-22
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2020-05-22
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-05-22
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 2020-06-22
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-06-22
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-06-22
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
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 2001-05-14
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2001-05-14
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2001-05-14
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 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
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2009-02-09
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2014-07-29
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
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 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
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 2015-12-17
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2015-12-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2015-12-17
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 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 2013-01-07
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2013-01-07
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2013-01-07
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2018-06-08
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
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2020-09-22
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2020-09-04
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
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
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
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
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
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2019-06-24
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
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
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
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
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
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
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
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
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 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
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
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
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

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
K191007 Supersonic Imagine Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems 2019-10-25
K974588 Rimed , Ltd. INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD 1998-08-07
K142628 Siemens Medi Cal Solutions, Inc. Acuson SC2000 Diagnostic Ultrasound System 2014-10-10
K132171 Supersonic Imagine AIXPLORER 2013-09-24
K222441 Bk Medical Aps Ultrasound System 2300 2022-12-07

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0189-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Z-0190-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Z-0191-2022 FujiFilm Healthcare Americas Corporation 2
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Z-0192-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
Z-1884-2024 FUJIFILM Healthcare Americas Corporation 2
Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24

Similar Registrations

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3025786376 ACO HEALTHCARE CO., LTD. Taoyuan City, TW
3004752776 Compumedics Germany GmbH Singen Baden-Wurttemberg, DE
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017894900. Last updated year: 2026. Please use registration number 3017894900 when referencing this establishment in official correspondence.
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