Clearance Summary
MRI ULTRAVIEW received FDA 510(k) clearance under submission number K915260, sponsored by A&E Specialty Fabricators. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1992-03-16.
- Submission: K915260
- Applicant / Sponsor: A&E Specialty Fabricators
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 1992-03-16
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.