Clearance Summary
MR-GUIDE 2000 received FDA 510(k) clearance under submission number K013150, sponsored by Ultraguide , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2001-10-18.
- Submission: K013150
- Applicant / Sponsor: Ultraguide , Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 2001-10-18
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.