Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T— 510(k) K232021

Substantially Equivalent

Philips Healthcare (Suzhou) Co., Ltd.

FDA 510(k) clearance K232021 for Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T, Substantially Equivalent on 2023-09-01. Applicant: Philips Healthcare (Suzhou) Co., Ltd..

Clearance details

Applicant: Philips Healthcare (Suzhou) Co., Ltd.
Product code: Code MOS
Advisory panel: Radiology
Date received: 2023-07-07
Decision date: 2023-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

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