Clearance Summary
COLLIMATOR MODEL A280BLE & MODEL A280-BLM received FDA 510(k) clearance under submission number K861942, sponsored by D&R X-Ray Products, 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 1986-07-25.
- Submission: K861942
- Applicant / Sponsor: D&R X-Ray Products, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1610
- Decision date: 1986-07-25
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.