# K213113: Orthoscan Tau Mini C-Arm

- Pathway: 510(k) (Special)
- Applicant: Orthoscan, Inc.
- Decided: Oct 21, 2021 after 24 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: 7 generations back to K003266 (2000). 12 ancestors in all.
3 later devices descend from it; 2 cite it directly.
1 of 16 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183220: OrthoScan TAU Mini C-Arm, Orthoscan, Inc. (2019) Summary page 5.

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

## Indications for use
The Orthoscan TAU Mini C-arm 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/K213113
Methodology: https://510kreport.com/methodology