Cleared Traditional

MC2 Portable X-ray System

K241567 · Oxos Medical · Radiology

Dec 2024

Decision

189d

Days

Class 2

Risk

About This 510(k) Submission

K241567 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 6, 2024, 189 days after receiving the submission on May 31, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K241567 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 31, 2024
Decision Date	December 06, 2024
Days to Decision	189 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