# K243452: Orthoscan VERSA Mini C-Arm

- Pathway: 510(k) (Traditional)
- Applicant: Ziehm-Orthoscan, Inc.
- Decided: Jan 14, 2025 after 68 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
Longest line of descent: 8 generations back to K003266 (2000). 14 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 17 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213113: Orthoscan Tau Mini C-Arm, Orthoscan, Inc. (2021) Summary page 5.
- K113708: Orthoscan Mobile DI Mini C-Arm, Orthoscan, Inc. (2012) Summary page 5.

## Most influential descendants
- 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
- Sep 3, 2026 · Not classified · Z-0286-2027: The accessory cart weldment does not conform to weld dimensional specifications which may result in separation of the monitor arm mounting structure from the cart.

## Indications for use
The Orthoscan VERSA Mini C-arm X-ray system is designed to provide physicians with general fluoroscopic visualization, using pulsed or continuous fluoroscopy, of a patient including but not limited to, diagnostic, surgical, and critical emergency care procedures for patients of all ages including pediatric populations when imaging limbs/extremities, shoulders, at locations including but not limited to, hospitals, ambulatory surgery, emergency, traumatology, orthopedic, critical care, or physician office environments.

Source page: https://510kreport.com/device/K243452
Methodology: https://510kreport.com/methodology