FDA.report

510(k) K252068

Device
MC2 Portable X-ray System
Applicant
Oxos Medical
510(k) number
K252068
Product code
OWB
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-22
Date received
2025-07-01
Regulation
892.1650
Classification name
Interventional Fluoroscopic X-Ray System
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Dhruv Vishwakarma
Address
1100 Peachtree Rd. NE Suite 700 Atlanta GA US 30309 30309

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code OWB

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K254186Azurion R3.1Philips Medical Systems B.V.2026-01-16
K251893SKAN C PULSARSkanray Technologies Limited2025-12-16
K251199Allia MoveoGE Medical Systems SCS2025-12-09
K250241Cios SelectSiemens Medical Solutions USA, Inc.2025-11-04
K251827Azurion R3.1Philips Medical Systems B.V.2025-10-24
K251602Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve ImagingCanon Medical Systems Corporation2025-10-10
K251523Cios SpinSiemens Medical Solutions USA, Inc.2025-07-29