Clearance Summary
BENNETT X-RAY DIGITAL SPOT IMAGER received FDA 510(k) clearance under submission number K935428, sponsored by Bennett X-Ray Technologies. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1994-11-01.
- Submission: K935428
- Applicant / Sponsor: Bennett X-Ray Technologies
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1710
- Decision date: 1994-11-01
Classification & Regulation
This clearance is catalogued under FDA product code IZH and 21 CFR 892.1710, within the Radiology review panel as a Class II device.