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510(k) K252068

MC2 Portable X-ray System by Oxos Medical — Product Code OWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2025
Date Received
July 1, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Interventional Fluoroscopic X-Ray System
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Interventional fluoroscopy

Other clearances by Oxos Medical

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  • K212654 — Micro C Medical Imaging System, M01 (February 4, 2022)
  • K211473 — Micro C Medical Imaging System, M01 (June 4, 2021)
  • K203658 — Micro C Medical Imaging System, M01 (January 12, 2021)

Other clearances for product code OWB

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  • K251992 — ArmSure Fluoroscopic Positioning System (February 11, 2026)
  • K254186 — Azurion R3.1 (January 16, 2026)
  • K251893 — SKAN C PULSAR (December 16, 2025)
  • K251199 — Allia Moveo (December 9, 2025)
  • K250241 — Cios Select (November 4, 2025)
  • K251827 — Azurion R3.1 (October 24, 2025)
  • K251602 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (October 10, 2025)
  • K251523 — Cios Spin (July 29, 2025)