Clearance Summary
Dental Cone Beam Computed Tomography System received FDA 510(k) clearance under submission number K260662, sponsored by Yofo Medical Technology Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2026-06-04.
- Submission: K260662
- Applicant / Sponsor: Yofo Medical Technology Co., Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1750
- Decision date: 2026-06-04
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.