Philips Ultrasound (Shanghai) Co., Ltd

FDA Device Registration & Listing · SHANGHAI, CN · Registration 3005403518

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
3005403518
FEI Number
3005403518
Entity Name
Philips Ultrasound (Shanghai) Co., Ltd
City/State/Country
SHANGHAI, CN
Establishment Address
Building 5, 3000 Longdong Boulevard, Suite 102, Suite 203, Suite 702, SHANGHAI 201203, CN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
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
N/A
PMA Number
N/A

All Registered Proprietary Names

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 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 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 ClearVue 350 Diagnostic Ultrasound System ClearVue 650 Diagnostic Ultrasound System ClearVue 550 Diagnostic Ultrasound System ClearVue 850 Diagnostic Ultrasound System L12-5 iU22 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 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 5C2A Curved Linear Array Transducer 8V3A Sector Transducer 8EC4A Curved Array Transducer 12L5A Linear Array Transduce 4V2A Sector Transducer 8V3A Sector Transducer 12L5A Linear Array Transducer 8EC4A Curved Array Transducer 9MC3 Curved Array Transducer 5C2A Curved Linear Array Transducer 4V2A Sector Transducer 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 C5-1 iU22 Diagnostic Ultrasound System S3 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 HD11 Diagnostic Ultrasound System BP10-5ec V6-2 C6-3 V8-4 L9-3 Flash Ultrasound System 5100 Point of Care 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

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 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
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 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 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 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
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 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 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
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
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 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 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 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
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
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 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

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
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005403518. Last updated year: 2026. Please use registration number 3005403518 when referencing this establishment in official correspondence.
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