Clearance Summary
IMAGYN 125 I SEED, MODEL IS 125 received FDA 510(k) clearance under submission number K982421, 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 1998-07-31.
- Submission: K982421
- Applicant / Sponsor: International Isotopes, Inc.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5730
- Decision date: 1998-07-31
Classification & Regulation
This clearance is catalogued under FDA product code IWG and 21 CFR 892.5730, within the Radiology review panel as a Class II device.