Clearance Summary
FLUORO AUTOMATIC BRIGHTNESS SYS received FDA 510(k) clearance under submission number K812217, sponsored by Keystone X-Ray, 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 1981-09-16.
- Submission: K812217
- Applicant / Sponsor: Keystone X-Ray, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 1981-09-16
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.