Clearance Summary
BENNETT X-RAY ID PLUS received FDA 510(k) clearance under submission number K925332, 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 1992-11-27.
- Submission: K925332
- Applicant / Sponsor: Bennett X-Ray Technologies
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1640
- Decision date: 1992-11-27
Classification & Regulation
This clearance is catalogued under FDA product code JAC and 21 CFR 892.1640, within the Radiology review panel as a Class I device.