Clearance Summary
I-125 RAPID STRAND received FDA 510(k) clearance under submission number K940632, sponsored by Medi-Physics Inc. Dba Nycomed Amersham Imaging. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1994-09-02.
- Submission: K940632
- Applicant / Sponsor: Medi-Physics Inc. Dba Nycomed Amersham Imaging
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5730
- Decision date: 1994-09-02
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.