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510(k) K233875

Brainomix 360 e-Lung by Brainomix Limited — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2024
Date Received
December 7, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
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)
  • K232496 — Brainomix 360 Triage Stroke (November 21, 2023)
  • K231837 — Brainomix 360 Triage LVO (September 28, 2023)
  • K231656 — Brainomix 360 e-MRI (August 30, 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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  • K260166 — Bunkerhill Contrast CAC (March 6, 2026)
  • K260169 — AV Cardiac CT (March 5, 2026)
  • K253173 — uCT 780 with uWS-CT-Dual Energy Analysis (January 20, 2026)
  • K252217 — CT VScore+ (November 28, 2025)
  • K251805 — syngo.CT Dual Energy (October 15, 2025)
  • K250662 — Bunkerhill MAC (October 3, 2025)
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