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510(k) K250221

StrokeSENS ASPECTS Software Application by Circle Cardiovascular Imaging, Inc. — Product Code POK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2025
Date Received
January 24, 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 Circle Cardiovascular Imaging, Inc.

  • K251027 — cvi42 Coronary Plaque Software Application (October 27, 2025)
  • K242781 — cvi42 Software Application (October 15, 2024)
  • K241038 — Cardiac CT Function Software Application (June 7, 2024)
  • K232661 — Myocardial Strain Software Application (December 7, 2023)
  • K222593 — TruPlan Computed Tomography (CT) Imaging Software (January 18, 2023)
  • K213998 — cvi42 Auto Imaging Software Application (July 28, 2022)
  • K202212 — TruPlan (February 19, 2021)
  • K141480 — CVI42 (August 22, 2014)
  • K111373 — CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE (August 23, 2011)
  • K082628 — CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23 (November 20, 2008)

Other clearances for product code POK

  • K251769 — RevealAI-Lung (January 30, 2026)
  • K252294 — Fetal EchoScan (v1.2) (December 8, 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)
  • K233342 — CINA-ASPECTS (March 15, 2024)