FDA 510(k)

ATUSA™ Sistema Automatizado de Ultrasonido 3D de Mama

N.º K: K213620 · 2022-04-22

Fecha de decisión2022-04-22

Código de productoIYO

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

ATUSA™ Automated 3D Breast Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Isono Health, Inc.. It received FDA 510(k) clearance on 2022-04-22 under 510(k) number K213620. 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 ATUSA™ Automated 3D Breast Ultrasound System?

ATUSA™ Automated 3D Breast Ultrasound System is a medical device that received FDA 510(k) clearance on 2022-04-22. The listed applicant is Isono Health, Inc.. The 510(k) number is K213620.

When did ATUSA™ Automated 3D Breast Ultrasound System receive FDA 510(k) clearance?

ATUSA™ Automated 3D Breast Ultrasound System received FDA 510(k) clearance on 2022-04-22, under 510(k) number K213620.

Who is the listed applicant for ATUSA™ Automated 3D Breast Ultrasound System?

The FDA 510(k) record lists Isono Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ATUSA™ Automated 3D Breast Ultrasound System?

The FDA product code for ATUSA™ Automated 3D Breast Ultrasound System is IYO.

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Fuente oficial

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