Clearance Summary
I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401 received FDA 510(k) clearance under submission number K992963, sponsored by International Isotopes, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1999-09-21.
- Submission: K992963
- Applicant / Sponsor: International Isotopes, Inc.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5730
- Decision date: 1999-09-21
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.