Class Class II
OnyxCeph (K213263)
Description
OnyxCeph by Image Instruments GmbH, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK213263
Clearance Date2023-01-04
Clearance TypeTraditional
Product CodeLLZ
Regulation Number892.2050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K213263
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. OnyxCeph (K213263) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K192475 | NemoFAB | Software Nemotec S.L. | 2020 |
| K171634 | Ortho System | 3Shape A/S | 2018 |
| K053010 | VISTADENT AT COMPLETE, MODEL 3.1 | Dentsply Intl., Inc. | 2005 |
Trace the full predicate network for K213263
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.