Class Class II
AudaxCeph Cephalogram Analysis Software (K243005)
Description
AudaxCeph Cephalogram Analysis Software by Audax D.O.O., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243005
Clearance Date2025-05-30
Clearance TypeTraditional
Product CodeQIH
Regulation Number892.2050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243005
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. AudaxCeph Cephalogram Analysis Software (K243005) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231396 | CEPHX- Cephalometric Analysis Software | Orca Dental AI , Ltd. | 2024 |
Trace the full predicate network for K243005
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.