FDA 510(k)

Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3)

N.º K: K172951 · 2017-10-24

Fecha de decisión2017-10-24

Código de productoMQB

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3) is the device name listed in this FDA 510(k) record. The listed applicant is Varex Imaging Corporation. It received FDA 510(k) clearance on 2017-10-24 under 510(k) number K172951. 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 Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3)?

Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3) is a medical device that received FDA 510(k) clearance on 2017-10-24. The listed applicant is Varex Imaging Corporation. The 510(k) number is K172951.

When did Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3) receive FDA 510(k) clearance?

Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3) received FDA 510(k) clearance on 2017-10-24, under 510(k) number K172951.

Who is the listed applicant for Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3)?

The FDA 510(k) record lists Varex Imaging Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3)?

The FDA product code for Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3) is MQB.

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Otros registros que enlistan a Varex Imaging Corporation como solicitante

K253103Nexus DRF Digital X-ray Imaging System K193238Nexus DR Digital X-Ray Imaging System (with vSharp)K190146Nexus DR Digital X-ray Imaging System K183212Nexus DR Digital X-ray Imaging System with stitching K181526XRpad2 4343 HWC-M Flat Panel Detector K171138Nexus DR Digital X-ray Imaging System

Ver todos los 7 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

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