Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2518586

FEI Number

2518586

Entity Name

Philips Ultrasound LLC

City/State/Country

Reedsville, PA, US

Establishment Address

1 Echo Dr, Reedsville, PA 17084, US

Establishment Type(s)

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

K172607

PMA Number

N/A

All Registered Proprietary Names

Lumify Diagnostic Ultrasound System C8-4v 3D6-2 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 Affiniti Series Diagnostic Ultrasound System EPIQ Series Diagnostic Ultrasound System Affiniti Series Diagnostic Ultrasound System Epiq Series Diagnostic Ultrasound System C5-1 iU22 Diagnostic Ultrasound System Xperius Ultrasound System C5-2 S4-1 L12-4 Lumify Ultrasound System Affiniti Series Diagnostic Ultrasound System EPIQ Series Diagnostic Ultrasound System HD11 Diagnostic Ultrasound System BP10-5ec V6-2 C6-3 V8-4 L9-3 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 S5-1 D2cwc CX50 Diagnostic Ultrasound System X7-2t 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 EPIQ Series Diagnostic Ultrasound System Affiniti Series Diagnostic Ultrasound System X3-1 S5-1 iE33 Diagnostic Ultrasound System iU22 Diagnostic Ultrasound System Philips ultrasound probe 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 C9-4ec Transducer Lumify 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 ClearVue 350 Diagnostic Ultrasound System ClearVue 650 Diagnostic Ultrasound System ClearVue 550 Diagnostic Ultrasound System ClearVue 850 Diagnostic Ultrasound System EPIQ Series Diagnostic Ultrasound System Affiniti Series Diagnostic Ultrasound System VISIQ Diagnostic Ultrasound System C5-2 S5-1 C5-1 X7-2t L12-3 C9-3v D5cwc CX50 Diagnostic Ultrasound System D2cwc 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) L9-3 D2 TC L9-5 LAP S8-3 C9-5ec T6H X6-1 S7-2omni T6207 C10-3v X7-2t C9-4 VL13-5 S7-3t D5cwc S8-3t X5-1 C5-2 S12-4 S3-1 D2 CW L15-7io D2cwc iE33 Diagnostic Ultrasound System 3D9-3v iU22 Diagnostic Ultrasound System L12-5 50mm L11-3 L8-4 L17-5 D2tcd C8-5 V6-2 S4-1 X7-2 C8-4v L12-5 38mm Lumify 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 Epiq Series Diagnostic Ultrasound System Lumify Diagnostic Ultrasound System Lumify Diamond Select Diagnostic Ultrasound System Lumify Circular Edition Diagnostic Ultrasound System Xperius Ultrasound System EPIQ Series Diagnostic Ultrasound Systems 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 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 Lumify Ultrasound System C5-2 L12-4 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 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

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	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
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	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
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
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
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	2018-10-25
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-10-25
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-10-25
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	2025-07-22
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-07-22
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2025-07-22
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2025-07-22
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-07-22
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
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
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	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
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-11-23
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2025-11-23
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-11-23
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-11-23
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2025-11-23
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
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
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
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
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	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
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
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
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
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
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
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	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
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
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2026-06-09
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2026-06-09
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2026-06-09
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2026-06-09
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2026-06-09
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
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	2020-09-04
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
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
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	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
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
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

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

Registration Number	Establishment Name	Location
3029744051	LYSIS HEALTHCARE GMBH	Graz Steiermark, AT
3014574557	ADECHOTECH	NAVEIL Loir-et-Cher, FR
3012081348	THE SENTINEL IMAGING GROUP, INC	Clarks Summit, PA, US
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 2518586. Last updated year: 2026. Please use registration number 2518586 when referencing this establishment in official correspondence.