Clearance Summary
AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12 received FDA 510(k) clearance under submission number K033292, sponsored by Igc-Medical Advances, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2003-11-26.
- Submission: K033292
- Applicant / Sponsor: Igc-Medical Advances, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 2003-11-26
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.