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FDA 510(k)

X9 Ultrasound System

N.º K: K251673 · 2025-10-17

SolicitanteX9, Inc.
Fecha de decisión2025-10-17
Código de productoSGH
Comité asesorRA
DecisiónSubstantially Equivalent

Resumen del dispositivo

X9 Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is X9, Inc.. It received FDA 510(k) clearance on 2025-10-17 under 510(k) number K251673. The device is classified under product code SGH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the X9 Ultrasound System?

X9 Ultrasound System is a medical device that received FDA 510(k) clearance on 2025-10-17. The listed applicant is X9, Inc.. The 510(k) number is K251673.

When did X9 Ultrasound System receive FDA 510(k) clearance?

X9 Ultrasound System received FDA 510(k) clearance on 2025-10-17, under 510(k) number K251673.

Who is the listed applicant for X9 Ultrasound System?

The FDA 510(k) record lists X9, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X9 Ultrasound System?

The FDA product code for X9 Ultrasound System is SGH.

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Fuente oficial

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