FDA 510(k)

SR-8230, SR-8230S Portable X-ray Unit

N.º K: K200976 · 2020-06-10

SolicitanteShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)

Fecha de decisión2020-06-10

Código de productoIZL

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

SR-8230, SR-8230S Portable X-ray Unit is the device name listed in this FDA 510(k) record. The listed applicant is Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui). It received FDA 510(k) clearance on 2020-06-10 under 510(k) number K200976. 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 SR-8230, SR-8230S Portable X-ray Unit?

SR-8230, SR-8230S Portable X-ray Unit is a medical device that received FDA 510(k) clearance on 2020-06-10. The listed applicant is Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui). The 510(k) number is K200976.

When did SR-8230, SR-8230S Portable X-ray Unit receive FDA 510(k) clearance?

SR-8230, SR-8230S Portable X-ray Unit received FDA 510(k) clearance on 2020-06-10, under 510(k) number K200976.

Who is the listed applicant for SR-8230, SR-8230S Portable X-ray Unit?

The FDA 510(k) record lists Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SR-8230, SR-8230S Portable X-ray Unit?

The FDA product code for SR-8230, SR-8230S Portable X-ray Unit is IZL.

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Otros registros que enlistan a Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) como solicitante

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Dispositivos relacionados (Código: IZL)

K260236XLITEGEMSS HEALTHCARE CO., LTD.K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM Corporation K253185Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemCarestream Health K253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)Poskom Co., Ltd.K250976Airbile-100Poskom Co., Ltd.

Fuente oficial

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