Data / Medical devices / United States / Oxos Medical, Inc

Oxos Medical, Inc: FDA-registered device maker in Atlanta, GA, United States, 3 510(k) clearances

Name: Oxos Medical, Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Oxos Medical, Inc is registered with the FDA (registration 3018077344) in Atlanta, GA, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 22, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3018077344
Address: 1100 Peachtree St Ne Ste 700, Atlanta, GA, United States, 30309
Owner or operator: OXOS Medical, Inc (10080806)
Roles: Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler
First device listed: February 16, 2022
Registered through: 2026
Brand names listed: Cart, Emitter Tripod, ACSY-S015, Foot and Ankle Stand, Load Bearing Cassette Plate, ACSY-S009, MC2 Portable X-Ray System, MC2 Portable X-ray System, Micro C Foot Pedal, ACSY-P036, Micro C Medical Imaging System, M01 and more

Devices it lists

Device	Product code	Class	Role	Source
Image-Intensified Fluoroscopic X-Ray System, Mobile	OXO	2	Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler	accessdata.fda.gov
Interventional Fluoroscopic X-Ray System	OWB	2	Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Mobile	IZL	2	Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler	accessdata.fda.gov
Tube Mount, X-Ray, Diagnostic	IYB	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 22, 2025	K252068	MC2 Portable X-ray System	OWB	Substantially Equivalent	Oxos Medical	accessdata.fda.gov
December 6, 2024	K241567	MC2 Portable X-ray System	OWB	Substantially Equivalent	Oxos Medical	accessdata.fda.gov
February 4, 2022	K212654	Micro C Medical Imaging System, M01	IZL	Substantially Equivalent	Oxos Medical, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
June 11, 2026	99263	Class II	Ongoing	Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model/Catalog Number: MC2, MC2.1 Software Version: 5.7.0 Product Description: The MC2 Portable X-Ray System ( MC2 System or MC2 ) is a portable and ha	Due to a defective circuit board that overheats	accessdata.fda.gov

Compare with other makers

Updated August 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.