Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033527241

FEI Number

3033527241

Entity Name

Philips Global Business Services LLP - Ultrasound Business Unit

City/State/Country

Baner Pune Maharashtra, IN

Establishment Address

5th Floor, Amar Madhuban Tech Park, Baner Pune Maharashtra 411045, IN

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

Expiration Date (Year)

2026

510(k) Number

K093563

PMA Number

N/A

All Registered Proprietary Names

Q-Station QLAB Advanced Quantification Software 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 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 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 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 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 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 L12-4 S4-1 Lumify Diagnostic Ultrasound System iOS C5-2 Lumify Diagnostic Ultrasound System QLAB Advanced Quantification Software AAA Model S3 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 HD11 Diagnostic Ultrasound System BP10-5ec V6-2 C6-3 V8-4 L9-3 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 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 C9-4ec Transducer Lumify Diagnostic Ultrasound System ClearVue 350 Diagnostic Ultrasound System ClearVue 650 Diagnostic Ultrasound System ClearVue 550 Diagnostic Ultrasound System ClearVue 850 Diagnostic Ultrasound System 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 QLAB Advanced Quantification Software 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 Systems VISIQ Diagnostic Ultrasound System C5-2 C5-2 S4-1 L12-4 Lumify Ultrasound System Lumify Ultrasound System C5-2 L12-4 X3-1 S5-1 iE33 Diagnostic Ultrasound System iU22 Diagnostic Ultrasound System Philips ultrasound probe 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 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) Lumify Diagnostic Ultrasound System Lumify Diamond Select Diagnostic Ultrasound System Lumify Circular Edition 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 PercuNav Image Fusion And Interventional Navigation C5-1 iU22 Diagnostic Ultrasound System HDI 5000 Diagnostic Ultrasound System L12-5 38mm L12-5 50mm L12-5 iU22 Ultrasound System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2014-07-29
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2017-05-31
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
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
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	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
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	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
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	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
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2020-07-29
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	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
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
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	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
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	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	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	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
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2020-06-10
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
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
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
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
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
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
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
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
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	2013-08-27
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
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	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
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	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

Official Correspondent

No official correspondent registered.

US Agent Details

Ondrea Bermudez Email: Ondrea.Bermudez@philips.com Phone: (443) 3200028

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
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31
K122260	Aycan Digitalsysteme GmbH	AYCAN MOBILE	2012-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

Similar Registrations

Registration Number	Establishment Name	Location
3017991646	CARDIOWISE, INC.	Fayetteville, AR, US
3007120336	GE Healthcare Magyarorszag Kft.	Budapest, HU
3036758981	TAEYOUNG SOFT	Gwacheon-si Gyeonggi, KR
3010956703	Visual Medica	Ciudad Autonoma Buenos Aires Buenos Aires, Ciudad Autonoma de, AR
3030088963	REBRAIN	PESSAC Gironde, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033527241. Last updated year: 2026. Please use registration number 3033527241 when referencing this establishment in official correspondence.