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FDA 510(k)

Combined High Frequency X-ray Source

N.º K: K222258 · 2022-11-01

SolicitanteSuzhou Powersite Electric Co., Ltd.
Fecha de decisión2022-11-01
Código de productoIZL
Comité asesorRA
DecisiónSubstantially Equivalent

Resumen del dispositivo

Combined High Frequency X-ray Source is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Powersite Electric Co., Ltd.. It received FDA 510(k) clearance on 2022-11-01 under 510(k) number K222258. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Combined High Frequency X-ray Source?

Combined High Frequency X-ray Source is a medical device that received FDA 510(k) clearance on 2022-11-01. The listed applicant is Suzhou Powersite Electric Co., Ltd.. The 510(k) number is K222258.

When did Combined High Frequency X-ray Source receive FDA 510(k) clearance?

Combined High Frequency X-ray Source received FDA 510(k) clearance on 2022-11-01, under 510(k) number K222258.

Who is the listed applicant for Combined High Frequency X-ray Source?

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

What is the FDA product code for Combined High Frequency X-ray Source?

The FDA product code for Combined High Frequency X-ray Source is IZL.

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Fuente oficial

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