Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Philips Healthcare (Suzhou) Co., Ltd.

FDA 510(k) & PMA Approved Devices — 16 products

Total Devices16
Categories5
Latest Approval2026-03-23
TypeNumberDevice NameCodeDate
510(k) K252992 CT Rembra RT; CT Areta RT; CT Rembra JAK 2026-03-23 View
510(k) K260519 Smart Fit TorsoCardiac 1.5T MOS 2026-03-20 View
510(k) K242329 CT Collaboration Live LLZ 2024-11-18 View
510(k) K232491 CT 5300 JAK 2024-05-03 View
510(k) K233600 Smart Fit Knee 3.0T MOS 2024-02-05 View
510(k) K232021 Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T MOS 2023-09-01 View
510(k) K223311 Philips CT 3500 JAK 2022-12-22 View
510(k) K212441 Philips Incisive CT JAK 2022-04-27 View
510(k) K212864 dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T MOS 2021-12-01 View
510(k) K211168 Philips Incisive CT on Trailer JAK 2021-11-22 View
510(k) K203514 Precise Position JAK 2021-06-17 View
510(k) K201640 DuraDiagnost KPR 2020-07-09 View
510(k) K191136 Access CT JAK 2019-07-29 View
510(k) K173507 Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 LNH 2018-06-15 View
510(k) K180015 Philips Incisive CT JAK 2018-03-20 View
510(k) K163410 DigitalDiagnost C50 KPR 2017-01-04 View