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510(k) K231656

Brainomix 360 e-MRI by Brainomix Limited — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2023
Date Received
June 7, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

Other clearances by Brainomix Limited

  • K251983 — Brainomix 360 Triage Stroke (August 26, 2025)
  • K242411 — Brainomix 360 e-Lung (February 19, 2025)
  • K243294 — Brainomix 360 e-ASPECTS (February 14, 2025)
  • K242123 — Brainomix 360 e-CTA (January 6, 2025)
  • K233875 — Brainomix 360 e-Lung (May 13, 2024)
  • K232496 — Brainomix 360 Triage Stroke (November 21, 2023)
  • K231837 — Brainomix 360 Triage LVO (September 28, 2023)
  • K231195 — Brainomix 360 Triage ICH (July 27, 2023)
  • K223555 — Brainomix 360 e-CTP (June 1, 2023)
  • K221564 — Brainomix 360 e-ASPECTS (February 23, 2023)

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