Clearance Summary
LINEAR FR TOMOGRAPHIC SYSTEM: 0MT 8000, MODEL NO. 6681.270 received FDA 510(k) clearance under submission number K950571, sponsored by Continental 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 1995-03-31.
- Submission: K950571
- Applicant / Sponsor: Continental X-Ray Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1740
- Decision date: 1995-03-31
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.