# K252068: MC2 Portable X-ray System

- Pathway: 510(k) (Traditional)
- Applicant: Oxos Medical
- Decided: Dec 22, 2025 after 174 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- 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: 7 generations back to K973598 (1997). 9 ancestors in all.
No later device cites it as a predicate yet.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241567: MC2 Portable X-ray System, Oxos Medical (2024) Summary page 6.

## Recalls of this device
- Jun 11, 2026 · Class II · Z-2857-2026: Due to a defective circuit board that overheats

## Indications for use
The MC2 Portable X-ray System is indicated for use by qualified/trained medical professionals on adult and pediatric patients for: - Handheld orthopedic radiographic procedures of the extremities. - Handheld orthopedic serial radiographic procedures of the extremities, excluding the shoulder, hip, and knee. Handheld serial radiographic imaging is limited to forward holding position only. - Stand-mounted orthopedic radiographic, serial radiographic, fluoroscopic, and orthopedic interventional procedures of the extremities, inclusive of shoulders and knees. The device is NOT intended for use during surgery. The device is NOT intended to replace a stationary radiographic or fluoroscopic system, which may be required for optimization of image quality and radiation exposure. 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 Contraindications The MC2 System is contraindicated as follows: The MC2 System is NOT intended for bariatric patients. The MC2 System is NOT intended for mammography. The MC2 System is NOT intended for dental applications. The MC2 System is NOT intended to come in contact with non-intact skin. The MC2 System is NOT intended for cardiac applications. The MC2 System is NOT intended for use in proximity to pacemakers or implantable cardioverter-defibrillators (ICDs).

Source page: https://510kreport.com/device/K252068
Methodology: https://510kreport.com/methodology