Clearance Summary
BENNETT X-RAY TOMOGRAPHY SYSTEM received FDA 510(k) clearance under submission number K945749, sponsored by Bennett X-Ray Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1995-02-15.
- Submission: K945749
- Applicant / Sponsor: Bennett X-Ray Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1740
- Decision date: 1995-02-15
Classification & Regulation
This clearance is catalogued under FDA product code IZF and 21 CFR 892.1740, within the Radiology review panel as a Class II device.