Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)— 510(k) K161459

Name: FDA 510(k) clearance K161459
Creator: U.S. Food and Drug Administration
Published: 2016-09-06

Substantially Equivalent

Varian Medical Systems, X-Ray Products-Infimed

FDA 510(k) clearance K161459 for Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4), Substantially Equivalent on 2016-09-06. Applicant: Varian Medical Systems, X-Ray Products-Infimed. Device class: 2.

Clearance details

Applicant: Varian Medical Systems, X-Ray Products-Infimed
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2016-05-26
Decision date: 2016-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Liverpool, NY, US

Download summary PDF View on FDA.gov ↗

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