TELERADPRO EDGE; TELERADPRO EDGE HD-CCD— 510(k) K130636

Name: FDA 510(k) clearance K130636
Creator: U.S. Food and Drug Administration
Published: 2013-06-07

Substantially Equivalent

Vidar Systems Corp.

FDA 510(k) clearance K130636 for TELERADPRO EDGE; TELERADPRO EDGE HD-CCD, Substantially Equivalent on 2013-06-07. Applicant: Vidar Systems Corp.. Device class: 2.

Clearance details

Applicant: Vidar Systems Corp.
Product code: Code LMA
Device class: Class 2
Regulation: 21 CFR 892.2030
Advisory panel: Radiology
Date received: 2013-03-11
Decision date: 2013-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Herndon, VA, US

Download summary PDF View on FDA.gov ↗

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