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510(k) K221564

Brainomix 360 e-ASPECTS by Brainomix Limited — Product Code POK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2023
Date Received
May 31, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Device Class
Class II
Regulation Number
892.2060
Review Panel
RA
Submission Type

Assist users in characterizing lesions identified on acquired medical images

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)
  • K231656 — Brainomix 360 e-MRI (August 30, 2023)
  • K231195 — Brainomix 360 Triage ICH (July 27, 2023)
  • K223555 — Brainomix 360 e-CTP (June 1, 2023)

Other clearances for product code POK

  • K251769 — RevealAI-Lung (January 30, 2026)
  • K252294 — Fetal EchoScan (v1.2) (December 8, 2025)
  • K250221 — StrokeSENS ASPECTS Software Application (July 1, 2025)
  • K251071 — Fetal EchoScan (v1.1) (May 2, 2025)
  • K243614 — Sonio Suspect (February 21, 2025)
  • K243294 — Brainomix 360 e-ASPECTS (February 14, 2025)
  • K242130 — Koios DS (November 15, 2024)
  • K242342 — Fetal EchoScan (November 14, 2024)
  • K241245 — EchoSolv AS (October 4, 2024)
  • K234141 — AISAP Cardio V1.0 (August 1, 2024)