# K133174: Orthoscan FD Mini C-Arm

- Pathway: 510(k) (Traditional)
- Applicant: Orthoscan, Inc.
- Decided: Mar 28, 2014 after 162 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.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K183220: OrthoScan TAU Mini C-Arm (2019), 4 descendants of its own
- K213113: Orthoscan Tau Mini C-Arm (2021), 3 descendants of its own
- K243452: Orthoscan VERSA Mini C-Arm (2025), 2 descendants of its own
- K250587: Orthoscan TAU Mini C-Arm (2025), 1 descendant of its own
- K252579: Orthoscan TAU MVP Mini C-Arm System (2026), 0 descendants of its own

## Recalls of this device
- Aug 31, 2017 · Class II · Z-0261-2018: 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 

Source page: https://510kreport.com/device/K133174
Methodology: https://510kreport.com/methodology