FDA 510(k) Applications Submitted by Philips Healthcare (Suzhou) Co., Ltd.

FDA 510(k) Number Submission Date Device Name Applicant
K163410 12/05/2016 DigitalDiagnost C50 PHILIPS HEALTHCARE (SUZHOU) CO., LTD.
K180015 01/02/2018 Philips Incisive CT Philips Healthcare (Suzhou) Co., Ltd.
K141381 05/27/2014 DURADIAGNOST PHILIPS HEALTHCARE (SUZHOU) CO., LTD.
K173507 11/13/2017 Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 Philips Healthcare (Suzhou) Co., Ltd.
K232021 07/07/2023 Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T Philips Healthcare (Suzhou) Co., Ltd.
K201640 06/16/2020 DuraDiagnost Philips Healthcare (Suzhou) Co., Ltd.
K191136 04/29/2019 Access CT Philips Healthcare (Suzhou) Co., Ltd.
K211168 04/19/2021 Philips Incisive CT on Trailer Philips Healthcare (Suzhou) Co., Ltd.
K212441 08/04/2021 Philips Incisive CT Philips Healthcare (Suzhou) Co., Ltd.
K203514 11/30/2020 Precise Position Philips Healthcare (Suzhou) Co., Ltd.


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