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510(k) K242342

Fetal EchoScan by Brightheart — Product Code POK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2024
Date Received
August 7, 2024
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 Brightheart

  • K252294 — Fetal EchoScan (v1.2) (December 8, 2025)
  • K251456 — BrightHeart View Classifier (June 5, 2025)
  • K243684 — BrightHeart View Classifier (May 7, 2025)
  • K251071 — Fetal EchoScan (v1.1) (May 2, 2025)

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)
  • K241245 — EchoSolv AS (October 4, 2024)
  • K234141 — AISAP Cardio V1.0 (August 1, 2024)
  • K233342 — CINA-ASPECTS (March 15, 2024)