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FDA 510(k)

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

K-Number: K172951 · 2017-10-24

ApplicantVarex Imaging Corporation
Decision Date2017-10-24
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Varex Imaging Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253103Nexus DRF Digital X-ray Imaging SystemK193238Nexus DR Digital X-Ray Imaging System (with vSharp)K190146Nexus DR Digital X-ray Imaging SystemK183212Nexus DR Digital X-ray Imaging System with stitchingK181526XRpad2 4343 HWC-M Flat Panel DetectorK171138Nexus DR Digital X-ray Imaging System

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Related Devices (Code: MQB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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) LimitedK250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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