FDA 510(k)

B-Scan

Número K: K243227 · 2025-07-11

RequerenteAccutome, Inc. Doing Business AS Keeler USA

Data da decisão2025-07-11

Código do produtoIYO

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

B-Scan is the device name listed in this FDA 510(k) record. The listed applicant is Accutome, Inc. Doing Business AS Keeler USA. It received FDA 510(k) clearance on 2025-07-11 under 510(k) number K243227. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the B-Scan?

B-Scan is a medical device that received FDA 510(k) clearance on 2025-07-11. The listed applicant is Accutome, Inc. Doing Business AS Keeler USA. The 510(k) number is K243227.

When did B-Scan receive FDA 510(k) clearance?

B-Scan received FDA 510(k) clearance on 2025-07-11, under 510(k) number K243227.

Who is the listed applicant for B-Scan?

The FDA 510(k) record lists Accutome, Inc. Doing Business AS Keeler USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for B-Scan?

The FDA product code for B-Scan is IYO.

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Fonte oficial

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