Class Class II
Ziehm Vision RFD 3D (K243303)
Description
Ziehm Vision RFD 3D by Ziehm Imaging GmbH, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243303
Clearance Date2025-01-21
Clearance TypeTraditional
Product CodeOWB
Regulation Number892.1650
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243303
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. Ziehm Vision RFD 3D (K243303) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231701 | Ziehm Vision RFD 3D | Ziehm Imaging GmbH | 2023 |
Trace the full predicate network for K243303
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.