# K252579: Orthoscan TAU MVP Mini C-Arm System

- Pathway: 510(k) (Traditional)
- Applicant: Ziehm-Orthoscan, Inc.
- Decided: Jan 14, 2026 after 152 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: 11 generations back to K833587 (1983). 60 ancestors in all.
No later device cites it as a predicate yet.
1 of 61 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250587: Orthoscan TAU Mini C-Arm, Ziehm-Orthoscan, Inc. (2025) Summary page 5.
- K243020: MIDASVu, Intravu, Inc. (2024) Summary page 5.

## Indications for use
The Orthoscan TAU MVP 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. The scope used with Orthoscan TAU MVP system is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of interior cavity joints and other body cavities through a natural or surgical opening.

Source page: https://510kreport.com/device/K252579
Methodology: https://510kreport.com/methodology