# K241567: MC2 Portable X-ray System

- Pathway: 510(k) (Traditional)
- Applicant: Oxos Medical
- Decided: Dec 6, 2024 after 189 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- 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: 6 generations back to K973598 (1997). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211191: Virtual C DRF Digital Imaging System, Portavision Medical, LLC (2021) Summary page 5.

## Most influential descendants
- K252068: MC2 Portable X-ray System (2025), 0 descendants of its own

## Indications for use
The MC2 Portable X-ray System is indicated for use by qualified/trained medical professionals on adult patients for orthopedic radiographic, orthopedic serial radiographic, orthopedic fluoroscopic, and orthopedic interventional procedures of extremities distal to the shoulders and distal to the knees. The device is not intended for use during surgery. The device is not intended to replace a stationary radiographic system. The device is to be used in healthcare facilities where qualified operators are present (e.g., outpatient clinics, urgent cares, imaging centers, sports medicine facilities, occupational medicine clinics). The device is not intended to be used in environments with the following characteristics: -Aseptic or sterile fields, such as in surgery -Home or residential settings or other settings where qualified operators are not present -Vehicular and moving environments -Environments under direct sunlight -Oxygen-rich environments, such as near an operating oxygenation concentrator

Source page: https://510kreport.com/device/K241567
Methodology: https://510kreport.com/methodology