Clearance Summary
S-RAY CAMERA received FDA 510(k) clearance under submission number K863856, sponsored by Uni-Quatro Industries. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1986-10-14.
- Submission: K863856
- Applicant / Sponsor: Uni-Quatro Industries
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2040
- Decision date: 1986-10-14
Classification & Regulation
This clearance is catalogued under FDA product code LMC and 21 CFR 892.2040, within the Radiology review panel as a Class II device.