Clearance Summary
MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS received FDA 510(k) clearance under submission number K043557, sponsored by Panoramic Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2005-01-13.
- Submission: K043557
- Applicant / Sponsor: Panoramic Corp.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1800
- Decision date: 2005-01-13
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.