Clearance Summary
MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A received FDA 510(k) clearance under submission number K082485, sponsored by Neusoft Medical Systems 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 2008-09-09.
- Submission: K082485
- Applicant / Sponsor: Neusoft Medical Systems Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 2008-09-09
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.