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510(k) K232156

Rapid ASPECTS (v3) by Ischemaview, Inc. — Product Code POK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2024
Date Received
July 20, 2023
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 Ischemaview, Inc.

  • K251987 — Rapid Aortic Measurements (September 23, 2025)
  • K251533 — Rapid Obstructive Hydrocephalus, Rapid OH (September 4, 2025)
  • K252526 — Rapid DeltaFuse (August 26, 2025)
  • K251151 — Rapid CTA 360 (July 16, 2025)
  • K243378 — Rapid MLS (May 28, 2025)
  • K243350 — Rapid Neuro3D (January 22, 2025)
  • K233582 — Rapid (April 22, 2024)
  • K233512 — Rapid (6.0) (January 16, 2024)
  • K232436 — Rapid SDH (October 25, 2023)
  • K230074 — Rapid Aneurysm Triage and Notification (July 27, 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)