FDA 510(k)

Smart Fit TorsoCardiac 1.5T

Número K: K260519 · 2026-03-20

RequerentePhilips Healthcare (Suzhou) Co., Ltd.

Data da decisão2026-03-20

Código do produtoMOS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Smart Fit TorsoCardiac 1.5T 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 2026-03-20 under 510(k) number K260519. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Smart Fit TorsoCardiac 1.5T?

Smart Fit TorsoCardiac 1.5T is a medical device that received FDA 510(k) clearance on 2026-03-20. The listed applicant is Philips Healthcare (Suzhou) Co., Ltd.. The 510(k) number is K260519.

When did Smart Fit TorsoCardiac 1.5T receive FDA 510(k) clearance?

Smart Fit TorsoCardiac 1.5T received FDA 510(k) clearance on 2026-03-20, under 510(k) number K260519.

Who is the listed applicant for Smart Fit TorsoCardiac 1.5T?

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 TorsoCardiac 1.5T?

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

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Outros registros que listam Philips Healthcare (Suzhou) Co., Ltd. como candidato(a)

K252992CT Rembra RT; CT Areta RT; CT Rembra K242329CT Collaboration Live K232491CT 5300 K233600Smart Fit Knee 3.0T K232021Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T K223311Philips CT 3500

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Fonte oficial

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