FDA 510(k)

Astrasono A3Pro Bladder Scanner (A3Pro)

N.º K: K250331 · 2025-09-30

SolicitanteAstrasono Technology Co., Ltd.

Fecha de decisión2025-09-30

Código de productoIYO

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Astrasono A3Pro Bladder Scanner (A3Pro) is the device name listed in this FDA 510(k) record. The listed applicant is Astrasono Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-09-30 under 510(k) number K250331. 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 Astrasono A3Pro Bladder Scanner (A3Pro)?

Astrasono A3Pro Bladder Scanner (A3Pro) is a medical device that received FDA 510(k) clearance on 2025-09-30. The listed applicant is Astrasono Technology Co., Ltd.. The 510(k) number is K250331.

When did Astrasono A3Pro Bladder Scanner (A3Pro) receive FDA 510(k) clearance?

Astrasono A3Pro Bladder Scanner (A3Pro) received FDA 510(k) clearance on 2025-09-30, under 510(k) number K250331.

Who is the listed applicant for Astrasono A3Pro Bladder Scanner (A3Pro)?

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

What is the FDA product code for Astrasono A3Pro Bladder Scanner (A3Pro)?

The FDA product code for Astrasono A3Pro Bladder Scanner (A3Pro) is IYO.

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Fuente oficial

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