Clearance Summary
CESIUM 137 SOURCE, MODEL CSM-40 received FDA 510(k) clearance under submission number K882449, sponsored by Cis-Us, 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 1989-04-14.
- Submission: K882449
- Applicant / Sponsor: Cis-Us, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5730
- Decision date: 1989-04-14
Classification & Regulation
This clearance is catalogued under FDA product code IWI and 21 CFR 892.5730, within the Radiology review panel as a Class II device.