Clearance Summary
HYPERLUX 30 IMAGE SYSTEM received FDA 510(k) clearance under submission number K827489, sponsored by Cgr Medical Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1982-11-04.
- Submission: K827489
- Applicant / Sponsor: Cgr Medical Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 1982-11-04
Classification & Regulation
This clearance is catalogued under FDA product code JAA and 21 CFR 892.1650, within the Radiology review panel as a Class II device.