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FDA 510(k)

RADIANCE

K-Number: K112060 · 2012-01-06

ApplicantGmv Aerospace and Defence S.A.
Decision Date2012-01-06
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADIANCE is the device name listed in this FDA 510(k) record. The listed applicant is Gmv Aerospace and Defence S.A.. It received FDA 510(k) clearance on 2012-01-06 under 510(k) number K112060. 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?

RADIANCE is a medical device that received FDA 510(k) clearance on 2012-01-06. The listed applicant is Gmv Aerospace and Defence S.A.. The 510(k) number is K112060.

When did RADIANCE receive FDA 510(k) clearance?

RADIANCE received FDA 510(k) clearance on 2012-01-06, under 510(k) number K112060.

Who is the listed applicant for RADIANCE?

The FDA 510(k) record lists Gmv Aerospace and Defence S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RADIANCE?

The FDA product code for RADIANCE is MUJ.

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Related Devices (Code: MUJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260750Virtual Cone (1.0)Varian Medical Systems, Inc.K253050RadOncAIInformaiK260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.K252784eXaSkin PlusAnatomical Geometry S.L.K253078ART.1-USSeetreat Pty, Ltd.K252304syngo.via RT Image Suite VC10Varian 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.

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