Clearance Summary
FLEXICOIL - MALLEABLE RECEIVE-ONLY SURFACE COIL received FDA 510(k) clearance under submission number K020601, sponsored by Odin Medical Technologies , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2002-04-24.
- Submission: K020601
- Applicant / Sponsor: Odin Medical Technologies , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 2002-04-24
Classification & Regulation
This clearance is catalogued under FDA product code MOS and 21 CFR 892.1000, within the Radiology review panel as a Class II device.