MC2 Portable X-ray System

Basic Information

• Brand Name: MC2 Portable X-ray System
• Primary DI: 00850079606043
• Version / Model: MC2.1
• Company Name: OXOS Medical, Inc.
• Labeler DUNS: 080323883
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-25
• Public Version: 1
• Public Version Date: 2026-04-02
• Public Version Status: New
• Public Device Record Key: be5f6f1a-7bf7-4981-ab65-0f3ee65a78d4

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OWB	Interventional Fluoroscopic X-Ray System	Radiology	892.1650	2
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	892.1650	2
IZL	System, X-Ray, Mobile	Radiology	892.1720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37658	Hand-held basic diagnostic x-ray system, digital	An assembly of devices that comprise a digital general-purpose hand-held diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture and display and manipulation. It typically operates on battery power and is designed to be easily carried from location to location by a single operator. It is most commonly used in sports medicine or military applications. It consists of a modular configuration that can be upgraded by the addition of hardware or software components and/or accessories. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850079606043	GS1

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 0 – 29.9 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Altitude: Between 1000 ft below sea level and 8,000 ft above sea level
• Type: Storage Environment Humidity
• Temperature Range: 20 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Humidity
• Temperature Range: 20 – 90 Percent (%) Relative Humidity