Clearance Summary
ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D received FDA 510(k) clearance under submission number K043612, sponsored by Instrumentarium Corp. Imaging Division. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2005-02-09.
- Submission: K043612
- Applicant / Sponsor: Instrumentarium Corp. Imaging Division
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1800
- Decision date: 2005-02-09
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.