Clearance Summary
MSK EXTREME MR SCANNER, MODEL AA5000 received FDA 510(k) clearance under submission number K080048, sponsored by Oni Medical Systems, 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 2008-02-06.
- Submission: K080048
- Applicant / Sponsor: Oni Medical Systems, Inc.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 2008-02-06
Classification & Regulation
This clearance is catalogued under FDA product code LNH and 21 CFR 892.1000, within the Radiology review panel as a Class II device.