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. |
| K232491 |
08/17/2023 |
CT 5300 |
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. |
| K233600 |
11/09/2023 |
Smart Fit Knee 3.0T |
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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