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FDA 510(k)

Smart Fit Knee 3.0T

K-Number: K233600 · 2024-02-05

ApplicantPhilips Healthcare (Suzhou) Co., Ltd.
Decision Date2024-02-05
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Smart Fit Knee 3.0T is the device name listed in this FDA 510(k) record. The listed applicant is Philips Healthcare (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2024-02-05 under 510(k) number K233600. 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 Knee 3.0T?

Smart Fit Knee 3.0T is a medical device that received FDA 510(k) clearance on 2024-02-05. The listed applicant is Philips Healthcare (Suzhou) Co., Ltd.. The 510(k) number is K233600.

When did Smart Fit Knee 3.0T receive FDA 510(k) clearance?

Smart Fit Knee 3.0T received FDA 510(k) clearance on 2024-02-05, under 510(k) number K233600.

Who is the listed applicant for Smart Fit Knee 3.0T?

The FDA 510(k) record lists Philips Healthcare (Suzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Smart Fit Knee 3.0T?

The FDA product code for Smart Fit Knee 3.0T is MOS.

Other records listing Philips Healthcare (Suzhou) Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252992CT Rembra RT; CT Areta RT; CT RembraK260519Smart Fit TorsoCardiac 1.5TK242329CT Collaboration LiveK232491CT 5300K232021Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5TK223311Philips CT 3500

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Related Devices (Code: MOS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0TPhilips Medical Systems Nederland B.V.K262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0TPhilips Medical Systems Nederland B.V.K2609470.55T 12Ch Breast CoilNeocoil, LLCK252587HD 8Ch Wrist ArrayShenzhen RF Tech Co., Ltd.K252876GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive OnlyShenzhen RF Tech Co., Ltd.K260519Smart Fit TorsoCardiac 1.5TPhilips Healthcare (Suzhou) Co., Ltd.

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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