Clearance Summary
NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230 received FDA 510(k) clearance under submission number K091546, sponsored by Noras Mri Products GmbH. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2009-06-24.
- Submission: K091546
- Applicant / Sponsor: Noras Mri Products GmbH
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 2009-06-24
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.