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Philips Healthcare (Suzhou) Co., Ltd.: FDA-registered device maker in Suzhou Jiangsu, China, 12 510(k) clearances

Name: Philips Healthcare (Suzhou) Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Philips Healthcare (Suzhou) Co., Ltd. is registered with the FDA (registration 3009529630) in Suzhou Jiangsu, China. It lists 4 device types. The FDA files 12 510(k) clearances under its listings, the newest dated March 23, 2026. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009529630
Address: No. 258, Zhongyuan Road Suzhou Industrial Park, Suzhou Jiangsu, China, 215024
Owner or operator: Philips Medical Systems International BV (1217116)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: November 3, 2014
Registered through: 2026
Brand names listed: CT 5300, CT Areta RT, CT Rembra, CT Rembra RT, DigitalDiagnost C50, DuraDiagnost, Incisive CT, Smart Fit Knee 3T and more

Devices it lists

Device	Product code	Class	Role	Source
Coil, Magnetic Resonance, Specialty	MOS	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)	MQB	2	Complaint file establishment, Specification developer	accessdata.fda.gov
System, X-Ray, Stationary	KPR	2	Complaint file establishment, Specification developer	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 23, 2026	K252992	CT Rembra RT; CT Areta RT; CT Rembra	JAK	Substantially Equivalent	Philips Healthcare (Suzhou) Co., Ltd.	accessdata.fda.gov
March 20, 2026	K260519	Smart Fit TorsoCardiac 1.5T	MOS	Substantially Equivalent	Philips Healthcare (Suzhou) Co., Ltd.	accessdata.fda.gov
May 3, 2024	K232491	CT 5300	JAK	Substantially Equivalent	Philips Healthcare (Suzhou) Co., Ltd.	accessdata.fda.gov
February 5, 2024	K233600	Smart Fit Knee 3.0T	MOS	Substantially Equivalent	Philips Healthcare (Suzhou) Co., Ltd.	accessdata.fda.gov
September 1, 2023	K232021	Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T	MOS	Substantially Equivalent	Philips Healthcare (Suzhou) Co., Ltd.	accessdata.fda.gov
April 27, 2022	K212441	Philips Incisive CT	JAK	Substantially Equivalent	Philips Healthcare (Suzhou) Co., Ltd.	accessdata.fda.gov
December 1, 2021	K212864	dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T	MOS	Substantially Equivalent	Philips Healthcare (Suzhou) Co., Ltd.	accessdata.fda.gov
July 10, 2020	K201725	DigitalDiagnost C50	KPR	Substantially Equivalent	Philips Healthcare (Suzhou) Co., Lit.	accessdata.fda.gov
July 9, 2020	K201640	DuraDiagnost	KPR	Substantially Equivalent	Philips Healthcare (Suzhou) Co., Ltd.	accessdata.fda.gov
March 20, 2018	K180015	Philips Incisive CT	JAK	Substantially Equivalent	Philips Healthcare (Suzhou) Co., Ltd.	accessdata.fda.gov
January 4, 2017	K163410	DigitalDiagnost C50	KPR	Substantially Equivalent	Philips Healthcare (Suzhou) Co., Ltd.	accessdata.fda.gov
June 12, 2014	K141381	DURADIAGNOST	KPR	Substantially Equivalent	Philips Healthcare (Suzhou) Co., Ltd.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
June 26, 2026	99511	Class II	Ongoing	Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.	Potential of failing to trigger clinical scan during Bolus Tracking.	accessdata.fda.gov
December 3, 2025	98238	Class II	Ongoing	Philips Incisive CT	Potential for incomplete scan due to unstable connection inside of floating sensor.	accessdata.fda.gov
December 23, 2022	93574	Class II	Ongoing	Incisive CT, model 728143 & 728144 running Software Version 5.0.0.	Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts or incorrect image orientation labels, or the need for a CT rescan. These include: 1. Artifacts may occur on perfusion images, 2. Orientation label reversed in 2D images, 3. Auto voice does not work during the cardiac scan, 4. Auto voice and operators voice are t	accessdata.fda.gov
February 24, 2021	87473	Class II	Terminated	Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed tomographic (CT) applications - Product Usage: intended for use in the head and whole body.	Philips has internally detected an issue with the actuators used in the Incisive CT couch, which could result in the couch failure to self-lock, and unexpectedly moving slowly downward to its limit position.	accessdata.fda.gov

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Updated August 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.