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510(k) K254161

Automated Aortic Stenosis Software (AutoAS) by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC — Product Code POK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2026
Date Received
December 22, 2025
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 GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

  • K260673 — LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Powe (March 24, 2026)
  • K253370 — LOGIQ Totus (January 8, 2026)
  • K253366 — LOGIQ Fortis (January 7, 2026)
  • K252328 — Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 (November 24, 2025)
  • K251985 — LOGIQ E10 (October 29, 2025)
  • K251963 — LOGIQ E10s (October 29, 2025)
  • K251322 — Venue; Venue Go; Venue Fit; Venue Sprint (July 25, 2025)
  • K251342 — EchoPAC Software Only / EchoPAC Plug-in (July 16, 2025)
  • K251169 — Vivid Pioneer (July 10, 2025)
  • K250543 — Voluson™ Performance 16; Voluson™ Performance 18 (May 29, 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)
  • K242342 — Fetal EchoScan (November 14, 2024)
  • K241245 — EchoSolv AS (October 4, 2024)
  • K234141 — AISAP Cardio V1.0 (August 1, 2024)