FDA 510(k)

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

K-Number: K172951 · 2017-10-24

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 a medical device manufactured by Varex Imaging Corporation. It received FDA 510(k) clearance on 2017-10-24 under approval 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. It is manufactured by Varex Imaging Corporation. The 510(k) number is K172951.

When was Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3) approved by the FDA?

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

What company makes 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 manufactured by Varex Imaging Corporation.

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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Related PubMed Literature

PMID: 42204020 A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal of imaging informatics in medicine (2026) PMID: 41476571 Digital pathology imaging artificial intelligence in cancer research and clinical trials: An NCI workshop report. Journal of pathology informatics (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 33371797 Developing a Qualification and Verification Strategy for Digital Tissue Image Analysis in Toxicological Pathology. Toxicologic pathology (2021)

Other Devices by Varex Imaging Corporation

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

Related Devices (Code: MQB)

K162555EVS 4343, EVS 4343GDRTECH Corporation K162344INNOLUX RICInnolux Corporation K161730Wireless Digital Flat Panel DetectorIray Technology (Shanghai) , Ltd. K162552EVS 3643, EVS 3643GDRTECH Corporation K163019CareView 750Cw/750C X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd. K160143ClearVision ExamVue Flat Panel DetectorJpi Healthcare, Inc.

Official Source

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