Clearance Summary
FLUOROSCOPIC BRIGHTNESS STABALIZER/FBS MODEL 9205A received FDA 510(k) clearance under submission number K926064, sponsored by Scientific Technology , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1993-04-27.
- Submission: K926064
- Applicant / Sponsor: Scientific Technology , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 1993-04-27
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.