Home / 510(k) Clearances / K242411

510(k) K242411

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2025
Date Received
August 14, 2024
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)
  • 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)
  • 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)

Other clearances for product code JAK

  • K260078 — Aquilion ServeSP (TSX-307B) V2.0 (March 13, 2026)
  • K252249 — Extremity CT Imaging System (March 13, 2026)
  • K260167 — Bunkerhill Contrast AVC (March 6, 2026)
  • 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)
  • K250766 — LungQ 4 (October 2, 2025)