Clearance Summary
CURIETRON 192 HIGH DOSE RATE received FDA 510(k) clearance under submission number K890799, 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 1989-10-27.
- Submission: K890799
- Applicant / Sponsor: Cis-Us, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5700
- Decision date: 1989-10-27
Classification & Regulation
This clearance is catalogued under FDA product code JAQ and 21 CFR 892.5700, within the Radiology review panel as a Class II device.