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510(k) K212654

Micro C Medical Imaging System, M01 by Oxos Medical, Inc. — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2022
Date Received
August 23, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, X-Ray, Mobile
Device Class
Class II
Regulation Number
892.1720
Review Panel
RA
Submission Type

Other clearances by Oxos Medical, Inc.

  • K252068 — MC2 Portable X-ray System (December 22, 2025)
  • K241567 — MC2 Portable X-ray System (December 6, 2024)
  • K211473 — Micro C Medical Imaging System, M01 (June 4, 2021)
  • K203658 — Micro C Medical Imaging System, M01 (January 12, 2021)

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  • K251710 — Mobile X-ray unit (!M1) (October 24, 2025)
  • K243864 — BONX805 (September 12, 2025)
  • K251443 — PROMO (August 22, 2025)
  • K251223 — HnX-P1, HnX-PB (August 4, 2025)
  • K250597 — REMEX Xcam6 (July 31, 2025)
  • K243473 — PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS (July 29, 2025)
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