Clearance Summary
GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L received FDA 510(k) clearance under submission number K111434, sponsored by Giotto USA, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2011-10-27.
- Submission: K111434
- Applicant / Sponsor: Giotto USA, LLC
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1715
- Decision date: 2011-10-27
Classification & Regulation
This clearance is catalogued under FDA product code MUE and 21 CFR 892.1715, within the Radiology review panel as a Class II device.