Clearance Summary
ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501 received FDA 510(k) clearance under submission number K991526, sponsored by Imagyn Medical Technologies, 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 1999-06-17.
- Submission: K991526
- Applicant / Sponsor: Imagyn Medical Technologies, Inc.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5730
- Decision date: 1999-06-17
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.