FDA 510(k)

B-Scan

N.º K: K243227 · 2025-07-11

SolicitanteAccutome, Inc. Doing Business AS Keeler USA

Fecha de decisión2025-07-11

Código de productoIYO

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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.

Dispositivos relacionados (Código: IYO)

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.