Clearance Summary
COLLIMAX X-RAY COLLIMATOR # R-182 received FDA 510(k) clearance under submission number K801168, sponsored by Ito X-Ray 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 1980-07-08.
- Submission: K801168
- Applicant / Sponsor: Ito X-Ray Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1610
- Decision date: 1980-07-08
Classification & Regulation
This clearance is catalogued under FDA product code IZX and 21 CFR 892.1610, within the Radiology review panel as a Class II device.