Radiance V3— 510(k) K153368

Name: FDA 510(k) clearance K153368
Creator: U.S. Food and Drug Administration
Published: 2016-02-16

Substantially Equivalent

Gmv Soluciones Globales Internet S.A.U.

FDA 510(k) clearance K153368 for Radiance V3, Substantially Equivalent on 2016-02-16. Applicant: Gmv Soluciones Globales Internet S.A.U.. Device class: 2.

Clearance details

Applicant: Gmv Soluciones Globales Internet S.A.U.
Product code: Code MUJ
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2015-11-23
Decision date: 2016-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madrid, ES

Download summary PDF View on FDA.gov ↗

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