# K221949: Ortho Device, ADAPTIX 3D Orthopedic Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Pausch Medical GmbH
- Decided: Jan 26, 2023 after 205 days
- Product code: IZF (System, X-Ray, Tomographic)
- Device class: 2
- Regulation: 21 CFR 892.1740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K862120 (1986). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183275: DR 800 with Tomosynthesis, Agfa N.V. (2019) Summary page 4.
- K113708: Orthoscan Mobile DI Mini C-Arm, Orthoscan, Inc. (2012) Summary page 4.

## Most influential descendants
- K252133: Adaptix Ortho350 (2025), 0 descendants of its own

## Indications for use
The Ortho Device is intended to generate tomosynthesis images of human anatomy for diagnostic purposes of the hand, elbow and foot in patients of all ages. The imaging will provide the physician visualized information about anatomical structures to facilitate assessment in orthopedic cases such as: • Fractures of bones in finger, metacarpus or wrist • Fractures of foot, ankle or elbow joint • Arthritis

Source page: https://510kreport.com/device/K221949
Methodology: https://510kreport.com/methodology