Cleared Traditional

MC2 Portable X-ray System

K252068 · Oxos Medical · Radiology

Dec 2025

Decision

174d

Days

Class 2

Risk

About This 510(k) Submission

K252068 is an FDA 510(k) clearance for the MC2 Portable X-ray System, a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by Oxos Medical (Atlanta, US). The FDA issued a Cleared decision on December 22, 2025, 174 days after receiving the submission on July 1, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K252068 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 01, 2025
Decision Date	December 22, 2025
Days to Decision	174 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	OWB — Interventional Fluoroscopic X-ray System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.1650
Definition	Interventional Fluoroscopy