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Philips Healthcare (Suzhou) Co., Ltd.

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

Total Devices16
Categories5
Latest FDA decision2026-03-23
TypeNumberDevice NameCodeDateActions
510(k) K252992 CT Rembra RT; CT Areta RT; CT RembraJAK2026-03-23 View
510(k) K260519 Smart Fit TorsoCardiac 1.5TMOS2026-03-20 View
510(k) K242329 CT Collaboration LiveLLZ2024-11-18 View
510(k) K232491 CT 5300JAK2024-05-03 View
510(k) K233600 Smart Fit Knee 3.0TMOS2024-02-05 View
510(k) K232021 Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5TMOS2023-09-01 View
510(k) K223311 Philips CT 3500JAK2022-12-22 View
510(k) K212441 Philips Incisive CTJAK2022-04-27 View
510(k) K212864 dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5TMOS2021-12-01 View
510(k) K211168 Philips Incisive CT on TrailerJAK2021-11-22 View
510(k) K203514 Precise PositionJAK2021-06-17 View
510(k) K201640 DuraDiagnostKPR2020-07-09 View
510(k) K191136 Access CTJAK2019-07-29 View
510(k) K173507 Prodiva 1.5T CX and Prodiva 1.5T CS R5.4LNH2018-06-15 View
510(k) K180015 Philips Incisive CTJAK2018-03-20 View
510(k) K163410 DigitalDiagnost C50KPR2017-01-04 View
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