Clearance Summary
10 CURIE IRDIUM 192, CSN00100-192 received FDA 510(k) clearance under submission number K991571, sponsored by Alpha-Omega Services, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2000-02-22.
- Submission: K991571
- Applicant / Sponsor: Alpha-Omega Services, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5730
- Decision date: 2000-02-22
Classification & Regulation
This clearance is catalogued under FDA product code KXK and 21 CFR 892.5730, within the Radiology review panel as a Class II device.