Class Class II
Orthoscan VERSA Mini C-Arm (K243452)
Description
Orthoscan VERSA Mini C-Arm by Ziehm-Orthoscan, Inc., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243452
Clearance Date2025-01-14
Clearance TypeTraditional
Product CodeOXO
Regulation Number892.1650
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243452
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. Orthoscan VERSA Mini C-Arm (K243452) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213113 | Orthoscan Tau Mini C-Arm | Orthoscan, Inc. | 2021 |
| K113708 | ORTHOSCAN MOBILE DI MINI C-ARM | Orthoscan, Inc. | 2012 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250587 | Orthoscan TAU Mini C-Arm | Ziehm-Orthoscan, Inc. | 2025 |
Trace the full predicate network for K243452
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.