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FDA 510(k)

Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)

K-Number: K161459 · 2016-09-06

ApplicantVarian Medical Systems, X-Ray Products-Infimed
Decision Date2016-09-06
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) is a medical device manufactured by Varian Medical Systems, X-Ray Products-Infimed. It received FDA 510(k) clearance on 2016-09-06 under approval number K161459. 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 DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)?

Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) is a medical device that received FDA 510(k) clearance on 2016-09-06. It is manufactured by Varian Medical Systems, X-Ray Products-Infimed. The 510(k) number is K161459.

When was Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) approved by the FDA?

Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) received FDA 510(k) clearance on 2016-09-06, under approval number K161459.

What company makes Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)?

Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) is manufactured by Varian Medical Systems, X-Ray Products-Infimed.

What is the FDA product code for Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)?

The FDA product code for Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) 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: 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)

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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.

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