Clearance Summary
GYREX PRIMA 1TG 1.0T MRI SYSTEM received FDA 510(k) clearance under submission number K970990, sponsored by Elscint Mr, 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 1997-08-25.
- Submission: K970990
- Applicant / Sponsor: Elscint Mr, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 1997-08-25
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.