Radiance V3
K-Number: K153368 · 2016-02-16
Decision Date2016-02-16
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Radiance V3 is a medical device manufactured by Gmv Soluciones Globales Internet S.A.U.. It received FDA 510(k) clearance on 2016-02-16 under approval number K153368. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Radiance V3?
Radiance V3 is a medical device that received FDA 510(k) clearance on 2016-02-16. It is manufactured by Gmv Soluciones Globales Internet S.A.U.. The 510(k) number is K153368.
When was Radiance V3 approved by the FDA?
Radiance V3 received FDA 510(k) clearance on 2016-02-16, under approval number K153368.
What company makes Radiance V3?
Radiance V3 is manufactured by Gmv Soluciones Globales Internet S.A.U..
What is the FDA product code for Radiance V3?
The FDA product code for Radiance V3 is MUJ.
Other Devices by Gmv Soluciones Globales Internet S.A.U.
Related Devices (Code: MUJ)
K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.
K161136Precision Treatment Planning SystemAccuray Incorporated
K160093RayStationRaySearch Laboratories AB (PUBL)
K151435MRCATPhilips Medical Systems MR Finland
K170750RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose ReviewBrainlab AG
K172163Eclipse Treatment Planning SystemVarian Medical Systems, Inc.
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.