X-VIEW, IMAGEN— 510(k) K151137

Substantially Equivalent

Edlen Imaging, LLC

FDA 510(k) clearance K151137 for X-VIEW, IMAGEN, Substantially Equivalent on 2016-06-07. Applicant: Edlen Imaging, LLC. Device class: 2.

Clearance details

Applicant: Edlen Imaging, LLC
Product code: Code OAS
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2015-04-29
Decision date: 2016-06-07
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Scottsdale, AZ, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.