Clearance Summary
HI-STAR MRI IMAGING SYSTEM received FDA 510(k) clearance under submission number K964778, sponsored by Health Images, 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 1997-02-24.
- Submission: K964778
- Applicant / Sponsor: Health Images, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 1997-02-24
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.