Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018077344

FEI Number

3018077344

Entity Name

OXOS MEDICAL, INC

City/State/Country

Atlanta, GA, US

Establishment Address

1100 Peachtree St Ne Ste 700, Atlanta, GA 30309, US

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198,Remanufacture Medical Device

Owner / Operator

OXOS Medical, Inc (Owner Number: 10080806)

Owner / Operator Contact Address

1100 Peachtree Street NE, Suite 700, Atlanta, GA 30309, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K252068

PMA Number

N/A

All Registered Proprietary Names

Emitter Tripod, ACSY-S015 Point of Care Cart, ACSY-S012 Weight Bearing Foot and Ankle System, ACSY-S016 Point of Care Cart Cassette Holder, ACSY-S014 OXBox Integrated Travel Case, ACSY-S021 Micro C Medical Imaging System, M01 Micro C Foot Pedal, ACSY-P036 Load Bearing Cassette Plate, ACSY-S009 MC2 Portable X-ray System Cart Wireless Foot Pedal Cart MC2 Portable X-Ray System Foot and Ankle Stand Wireless Foot Pedal

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IYB	Tube Mount, X-Ray, Diagnostic	Radiology	Class 1	892.1770	2022-03-31
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2022-02-16
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2024-12-19
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2024-12-19
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2024-12-19
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2026-01-07
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2026-01-07
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2026-01-07

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OXOS Medical, Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K153059	Minxray, Inc.	HF1202H PowerPlus Portable X-ray Equipment	2016-02-02
K060344	Breakaway Imaging, LLC	O-ARM IMAGING SYSTEM	2006-03-29
K982706	Philips Medical Systems, Inc.	PHILIPS BV300 SERIES RELEASE 2.1	1998-09-02
K163715	Philips Medical Systems Nederland B.V.	Allura Xper R9	2017-01-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-1470-2023	FUJIFILM Healthcare Americas Corporation	2	FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams
Z-3158-2024	FUJIFILM Healthcare Americas Corporation	2	The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.
Z-0001-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0002-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0003-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

Similar Registrations

Registration Number	Establishment Name	Location
3010583458	ZOGEAR Medical Co., Ltd.	Yizheng Jiangsu, CN
1225677	UMI INTL.	Norwood, NJ, US
8030233	SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION	KYOTO, JP
3012569470	VISARIS D.O.O.	Zemun Beograd, RS
2243057	Accogent Pausch	Tinton Falls, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018077344. Last updated year: 2026. Please use registration number 3018077344 when referencing this establishment in official correspondence.