Clearance Summary
MRI EQUIPMENT COVER received FDA 510(k) clearance under submission number K993682, sponsored by Image-Guided Neurologics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2000-01-20.
- Submission: K993682
- Applicant / Sponsor: Image-Guided Neurologics, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 2000-01-20
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.