Clearance Summary
CORSINI 9090 received FDA 510(k) clearance under submission number K950402, sponsored by C.A.T. DI Corsini G. & C. Spa. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1995-03-31.
- Submission: K950402
- Applicant / Sponsor: C.A.T. DI Corsini G. & C. Spa
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1980
- Decision date: 1995-03-31
Classification & Regulation
This clearance is catalogued under FDA product code IXR and 21 CFR 892.1980, within the Radiology review panel as a Class II device.