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FDA 510(k)

Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T

K-Number: K232021 · 2023-09-01

ApplicantPhilips Healthcare (Suzhou) Co., Ltd.
Decision Date2023-09-01
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T is a medical device manufactured by Philips Healthcare (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2023-09-01 under approval number K232021. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T?

Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T is a medical device that received FDA 510(k) clearance on 2023-09-01. It is manufactured by Philips Healthcare (Suzhou) Co., Ltd.. The 510(k) number is K232021.

When was Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T approved by the FDA?

Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T received FDA 510(k) clearance on 2023-09-01, under approval number K232021.

What company makes Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T?

Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T is manufactured by Philips Healthcare (Suzhou) Co., Ltd..

What is the FDA product code for Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T?

The FDA product code for Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T is MOS.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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