Philips Healthcare (Suzhou) Co., Ltd.
Philips Healthcare (Suzhou) Co., Ltd. holds FDA 510(k) medical device clearances, first cleared 2014, most recent 2026, with 4 FDA device recalls on record.
Top product codes for Philips Healthcare (Suzhou) Co., Ltd.
FDA recalls by Philips Healthcare (Suzhou) Co., Ltd.
- Z-2988-2026 — Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
- Z-1003-2026 — Philips Incisive CT
- Z-0640-2024 — Incisive CT, model 728143 & 728144 running Software Version 5.0.0.
- Z-1273-2021 — 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Philips Healthcare (Suzhou) Co., Ltd.
- K252992 — CT Rembra RT; CT Areta RT
- K260519 — Smart Fit TorsoCardiac 1.5T
- K242329 — CT Collaboration Live
- K232491 — CT 5300
- K233600 — Smart Fit Knee 3.0T
- K232021 — Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T
- K223311 — Philips CT 3500
- K212441 — Philips Incisive CT
- K212864 — dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T
- K211168 — Philips Incisive CT on Trailer
- K203514 — Precise Position
- K201640 — DuraDiagnost
- K191136 — Access CT
- K173507 — Prodiva 1.5T CX and Prodiva 1.5T CS R5.4
- K180015 — Philips Incisive CT
- K163410 — DigitalDiagnost C50
- K141381 — DURADIAGNOST
Data sourced from openFDA. This site is unofficial and independent of the FDA.