FDA 510(k)

Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W

N.º K: K201004 · 2020-05-01

SolicitanteIray Technology Taicang , Ltd.

Fecha de decisión2020-05-01

Código de productoMQB

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W is the device name listed in this FDA 510(k) record. The listed applicant is Iray Technology Taicang , Ltd.. It received FDA 510(k) clearance on 2020-05-01 under 510(k) number K201004. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W?

Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W is a medical device that received FDA 510(k) clearance on 2020-05-01. The listed applicant is Iray Technology Taicang , Ltd.. The 510(k) number is K201004.

When did Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W receive FDA 510(k) clearance?

Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W received FDA 510(k) clearance on 2020-05-01, under 510(k) number K201004.

Who is the listed applicant for Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W?

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

What is the FDA product code for Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W?

The FDA product code for Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W is MQB.

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Otros registros que enlistan a Iray Technology Taicang , Ltd. como solicitante

K223010Portable X-ray System K222886Mercu 1717V K221714Flat Panel Detector K221345Wireless Digital Flat Panel Detector K220536Digital flat panel detector K220668Wireless Digital Flat Panel Detector

Ver todos los 21 dispositivos →

Dispositivos relacionados (Código: MQB)

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) Limited K250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.