# K113708: Orthoscan Mobile DI Mini C-Arm

- Pathway: 510(k) (Traditional)
- Applicant: Orthoscan, Inc.
- Decided: Jan 5, 2012 after 20 days
- Product code: OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 4 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K243452: Orthoscan VERSA Mini C-Arm (2025), 2 descendants of its own
- K250587: Orthoscan TAU Mini C-Arm (2025), 1 descendant of its own
- K221949: Ortho Device, ADAPTIX 3D Orthopedic Imaging System (2023), 1 descendant of its own
- K252579: Orthoscan TAU MVP Mini C-Arm System (2026), 0 descendants of its own
- K252133: Adaptix Ortho350 (2025), 0 descendants of its own

## Recalls of this device
- Aug 31, 2017 · Class II · Z-0260-2018: OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital Zoom feature in the 

## Indications for use
The OrthoScan Mobile DI Mini C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures in hospital, emergency care, critical care, or physician office environments.

Source page: https://510kreport.com/device/K113708
Methodology: https://510kreport.com/methodology