Clearance Summary
ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray received FDA 510(k) clearance under submission number K152489, sponsored by Panoramic Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2016-02-04.
- Submission: K152489
- Applicant / Sponsor: Panoramic Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1750
- Decision date: 2016-02-04
Classification & Regulation
This clearance is catalogued under FDA product code OAS and 21 CFR 892.1750, within the Radiology review panel as a Class II device.