Clearance Summary
RADIANCE received FDA 510(k) clearance under submission number K112060, sponsored by Gmv Aerospace and Defence S.A.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2012-01-06.
- Submission: K112060
- Applicant / Sponsor: Gmv Aerospace and Defence S.A.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2012-01-06
Classification & Regulation
This clearance is catalogued under FDA product code MUJ and 21 CFR 892.5050, within the Radiology review panel as a Class II device.