# K250587: Orthoscan TAU Mini C-Arm

- Pathway: 510(k) (Special)
- Applicant: Ziehm-Orthoscan, Inc.
- Decided: Jul 2, 2025 after 125 days
- Product code: OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K003266 (2000). 15 ancestors in all.
1 later device descends 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.
- K243452: Orthoscan VERSA Mini C-Arm, Ziehm-Orthoscan, Inc. (2025) Summary page 5.

## Most influential descendants
- K252579: Orthoscan TAU MVP Mini C-Arm System (2026), 0 descendants of its own

## Indications for use
The Orthoscan TAU 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/K250587
Methodology: https://510kreport.com/methodology