# Philips Healthcare (Suzhou) Co., Ltd.

- Location (FDA's records): Suzhou, CN
- FDA decisions: 17 (2014–2026): 17 510(k) clearances
- Product codes: JAK (8), MOS (4), KPR (3), LLZ (1), LNH (1)
- 510(k) review time since 2016: median 90 days, against 121 for FDA's reviews in the same codes and years (8 of 16 faster)
- Predicates its devices cite: 26 (11 its own); citations of its devices by later devices: 13 (11 its own)
- Recalls linked to its devices: 37 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Philips Medical Systems (Cleveland), Inc.: 4 (https://510kreport.com/company/philips-medical-systems-cleveland)
- Invivo Corporation: 4 (https://510kreport.com/company/invivo)
- Mri Devices Corp.: 1 (https://510kreport.com/company/mri-devices)
- Philips Health Care: 1 (https://510kreport.com/company/philips-health-care)
- Philips Medical Systems Technologies, Ltd.: 1 (https://510kreport.com/company/philips-medical-systems-technologies)
- GE Medical Systems: 1 (https://510kreport.com/company/ge-medical-systems)
- Philips Medical Systems, Inc.: 1 (https://510kreport.com/company/philips-medical-systems)
- Swissray Medical AG: 1 (https://510kreport.com/company/swissray-medical)

## Firms that cite its devices most
- Philips Medical Systems Nederland B.V.: 1 (https://510kreport.com/company/philips-medical-systems-nederland)
- Philips Healthcare (Suzhou) Co., Lit.: 1 (https://510kreport.com/company/philips-healthcare-suzhou-co-lit)

## Its most-cited devices
- K180015: Philips Incisive CT (2018), cited by 4
- K212441: Philips Incisive CT (2022), cited by 2
- K141381: Duradiagnost (2014), cited by 2
- K211168: Philips Incisive CT on Trailer (2021), cited by 1
- K232021: Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T (2023), cited by 1
- K163410: DigitalDiagnost C50 (2017), cited by 1

## Recent decisions
- K252992: CT Rembra RT; CT Areta RT; CT Rembra (Mar 23, 2026)
- K260519: Smart Fit TorsoCardiac 1.5T (Mar 20, 2026)
- K242329: CT Collaboration Live (Nov 18, 2024)
- K232491: CT 5300 (May 3, 2024)
- K233600: Smart Fit Knee 3.0T (Feb 5, 2024)
- K232021: Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T (Sep 1, 2023)
- K223311: Philips CT 3500 (Dec 22, 2022)
- K212441: Philips Incisive CT (Apr 27, 2022)

Source page: https://510kreport.com/company/philips-healthcare-suzhou