Philips Healthcare (Suzhou) Co., Ltd.

FDA Device Registration & Listing · Suzhou Jiangsu, CN · Registration 3009529630

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
3009529630
FEI Number
3009529630
Entity Name
Philips Healthcare (Suzhou) Co., Ltd.
City/State/Country
Suzhou Jiangsu, CN
Establishment Address
No. 258, Zhongyuan Road, Suzhou Industrial Park, Suzhou Jiangsu 215024, CN
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
N
Expiration Date (Year)
2026
510(k) Number
K212864
PMA Number
N/A

All Registered Proprietary Names

DuraDiagnost Spectral CT on Rails Ingenuity TF Ingenuity Flex Brilliance 64 BrightView BrightView X SPECT Imaging Systems NM Application Suite Upgrade Spectral CT Verida RT Spectral CT Verida Upgrade Spectral CT Verida Upgrades Spectral CT 7500 RT SW5.4 Spectral CT Verida RT Upgrade Spectral CT 7500 SW5.4 Brilliance CT Big Bore Philips CT Big Bore 712201, DigitalDiagnost C50 Brilliance 16 Brilliance 16 Power CT Systems Brilliance 6 Ingenuity Core Ingenuity Core 128 CT Systems Ingenuity Vereos PET/CT Spectral CT 7500 RT GEMINI TF Big Bore PET/CT Imaging System 728351Multimodality Simulation Workspace (MM Sim) 1 Upgrade 728349 Multimodality Simulation Workspace (MM Sim) 1 GEMINI 16 PET/CT Imaging Systems GEMINI TF 64 GEMINI TF 16 Base TruFlight Select GEMINI TF 16 GEMINI TF 16 Ready GEMINI LXL Philips Gemini TF 16 Epiq Series Diagnostic Ultrasound System Affiniti Series Diagnostic Ultrasound System Epiq Series Diagnostic Ultrasound System Spectral CT IQon Spectral CT JETPack 2 dS MSK S 1.5T dS TorsoCardiac 1.5T dS MSK M 1.5T

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2014-11-03
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2014-11-03
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2022-05-23
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2017-10-12
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2017-10-12
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2009-06-16
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2007-11-21
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2009-05-18
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-13
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2017-11-27
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2017-10-24
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2009-06-16
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2016-08-10
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2021-06-02
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2021-06-02
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2024-11-06
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2009-05-28
MUJ System, Planning, Radiation Therapy Treatment Radiology Class 2 892.5050 2026-06-02
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2009-05-28
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2009-05-28
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2009-05-28
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2009-05-28
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
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
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-06-23
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2020-01-28
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2012-03-14
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-02-16

Official Correspondent

No official correspondent registered.

US Agent Details

Maria Heiling Business: Philips Email: maria.heiling@philips.com Phone: (858) 2487651

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
K070563 Vidar Systems Corp. VIDAR VISION 2000 2007-03-16
K190691 Pixxgen Corporation Pixx2430 Digital Diagnostic X-Ray Receptor Panel 2019-04-04
K150150 Rayence Co., Ltd. 1717SGN / 1717SCN Digital Flat Panel X-ray Detector 2015-03-27
K140771 Philips Medical Systems Dmc GmbH PHILIPS ELEVA WORKSPOT 2014-04-25
K201670 Siemens Medical Solutions USA, Inc. YSIO X.pree 2020-10-21

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2009 Toshiba American Medical Systems Inc 2
Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
Z-0031-2007 AGFA Corp. 2
CR DX-S, Image Intensified Fluoroscopic X-ray system.
Z-0002-2009 GE Medical Systems, LLC 2
Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434
Z-0002-2015 Siemens Medical Solutions USA, Inc 2
Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography. The Ysio Max uses integrated or portable digital detectors for generating diagnostic images by converting x-rays into electronic signals. Ysio Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
Z-0003-2009 GE Medical Systems, LLC 2
Revolution XR/d systems with control room PC model 5117866-2 with Software collector 5194381. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188. Intended for use in generating Tomographic images of human anatomy.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009529630. Last updated year: 2026. Please use registration number 3009529630 when referencing this establishment in official correspondence.
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