Class Class II
Ortho Device, ADAPTIX 3D Orthopedic Imaging System (K221949)
Description
Ortho Device, ADAPTIX 3D Orthopedic Imaging System by Pausch Medical GmbH, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221949
Clearance Date2023-01-26
Clearance TypeTraditional
Product CodeIZF
Regulation Number892.1740
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221949
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. Ortho Device, ADAPTIX 3D Orthopedic Imaging System (K221949) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K183275 | DR 800 with Tomosynthesis | Agfa N.V. | 2019 |
| K113708 | ORTHOSCAN MOBILE DI MINI C-ARM | Orthoscan, Inc. | 2012 |
Trace the full predicate network for K221949
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.