Clearance Summary
VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHALOMETRIC received FDA 510(k) clearance under submission number K030699, sponsored by J. Morita Mfg. Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2003-05-29.
- Submission: K030699
- Applicant / Sponsor: J. Morita Mfg. Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1830
- Decision date: 2003-05-29
Classification & Regulation
This clearance is catalogued under FDA product code EAG and 21 CFR 872.1830, within the Dental review panel as a Class II device.