Class Class II
Dental Cone Beam Computed Tomography System (K243337)
Description
Dental Cone Beam Computed Tomography System by Yofo Medical Technology Co., Ltd., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243337
Clearance Date2025-04-17
Clearance TypeTraditional
Product CodeOAS
Regulation Number892.1750
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243337
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Dental Cone Beam Computed Tomography System (K243337) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K162085 | i-CAT FLX V series / KaVo 3D eXam+ V series | Imaging Sciences International | 2016 |
Trace the full predicate network for K243337
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.