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FDA 510(k)

Nexus DR Digital X-Ray Imaging System (with vSharp)

K-Number: K193238 · 2019-12-20

ApplicantVarex Imaging Corporation
Decision Date2019-12-20
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Nexus DR Digital X-Ray Imaging System (with vSharp) is a medical device manufactured by Varex Imaging Corporation. It received FDA 510(k) clearance on 2019-12-20 under approval number K193238. 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 vSharp)?

Nexus DR Digital X-Ray Imaging System (with vSharp) is a medical device that received FDA 510(k) clearance on 2019-12-20. It is manufactured by Varex Imaging Corporation. The 510(k) number is K193238.

When was Nexus DR Digital X-Ray Imaging System (with vSharp) approved by the FDA?

Nexus DR Digital X-Ray Imaging System (with vSharp) received FDA 510(k) clearance on 2019-12-20, under approval number K193238.

What company makes Nexus DR Digital X-Ray Imaging System (with vSharp)?

Nexus DR Digital X-Ray Imaging System (with vSharp) is manufactured by Varex Imaging Corporation.

What is the FDA product code for Nexus DR Digital X-Ray Imaging System (with vSharp)?

The FDA product code for Nexus DR Digital X-Ray Imaging System (with vSharp) is MQB.

Related Clinical Trials

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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: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41883556 A clinician's quick‑start guide to implementing digital health innovations in the NHS - with lessons from a UK-deployed AI stroke imaging decision-support software. Digital health (2026) PMID: 41734979 Strategies to Increase Patients' Adherence to Digital Therapeutics for Musculoskeletal Diseases: A Narrative Review. Yonsei medical journal (2026)

Other Devices by Varex Imaging Corporation

K172951Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3) K171138Nexus DR Digital X-ray Imaging System K183212Nexus DR Digital X-ray Imaging System with stitching K181526XRpad2 4343 HWC-M Flat Panel Detector 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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