Clearance Summary
LIGHT BEAM COLLIMATOR received FDA 510(k) clearance under submission number K843244, sponsored by Dealers X-Ray Co., 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 1984-09-14.
- Submission: K843244
- Applicant / Sponsor: Dealers X-Ray Co., Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1610
- Decision date: 1984-09-14
Classification & Regulation
This clearance is catalogued under FDA product code IZW and 21 CFR 892.1610, within the Radiology review panel as a Class II device.