Clearance Summary
ROTOGRAPH PLUS received FDA 510(k) clearance under submission number K972968, sponsored by Chicago X-Ray Systems, 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 1997-10-08.
- Submission: K972968
- Applicant / Sponsor: Chicago X-Ray Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1800
- Decision date: 1997-10-08
Classification & Regulation
This clearance is catalogued under FDA product code EHD and 21 CFR 872.1800, within the Dental review panel as a Class II device.