Clearance Summary
MRI SYTEMS received FDA 510(k) clearance under submission number K113281, sponsored by Shenzhen Anke High-Tech 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 2012-05-17.
- Submission: K113281
- Applicant / Sponsor: Shenzhen Anke High-Tech Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 2012-05-17
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.