K232021

Substantially Equivalent

Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T

Applicant: Philips Healthcare (Suzhou) Co., Ltd.
Product 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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Data sourced from openFDA. This site is unofficial and independent of the FDA.