Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K161459 · 2016-09-06

Decision Date2016-09-06
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) is the device name listed in this FDA 510(k) record. The listed applicant is Varian Medical Systems, X-Ray Products-Infimed. It received FDA 510(k) clearance on 2016-09-06 under 510(k) 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. The listed applicant is Varian Medical Systems, X-Ray Products-Infimed. The 510(k) number is K161459.

When did Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) receive FDA 510(k) clearance?

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

Who is the listed applicant for Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)?

The FDA 510(k) record lists Varian Medical Systems, X-Ray Products-Infimed as the applicant. This does not by itself establish the device manufacturer.

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.

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.

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.