Clearance Summary
X-RAY TUBE - PANOBEAM received FDA 510(k) clearance under submission number K770345, sponsored by Thoro-Ray, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1977-03-08.
- Submission: K770345
- Applicant / Sponsor: Thoro-Ray, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1810
- Decision date: 1977-03-08
Classification & Regulation
This clearance is catalogued under FDA product code EAP and 21 CFR 872.1810, within the Dental review panel as a Class II device.