Clearance Summary
OPEN MAGNETIC RESONANCE IMAGING SYSTEM, MODEL MPF3000-III received FDA 510(k) clearance under submission number K091669, sponsored by Xioao Mdt Technology Co, 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 2009-06-18.
- Submission: K091669
- Applicant / Sponsor: Xioao Mdt Technology Co, Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 2009-06-18
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.