Rapid Aneurysm Triage and Notification— 510(k) K230074

Name: FDA 510(k) clearance K230074
Creator: U.S. Food and Drug Administration
Published: 2023-07-27

Substantially Equivalent

Ischemaview, Inc.

FDA 510(k) clearance K230074 for Rapid Aneurysm Triage and Notification, Substantially Equivalent on 2023-07-27. Applicant: Ischemaview, Inc.. Device class: 2.

Clearance details

Applicant: Ischemaview, Inc.
Product code: Code QFM
Device class: Class 2
Regulation: 21 CFR 892.2080
Advisory panel: Radiology
Date received: 2023-01-10
Decision date: 2023-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QFM

view all

K253751 — CXRDetectAI2026-07-08
K252954 — MammoSightAI2026-05-04
K252482 — CogNet AI-MT+2025-12-11
K250831 — Annalise Enterprise2025-04-23
K243808 — Rayvolve PTX-PE2025-03-21

More clearances from Ischemaview, Inc.

view all

K251987 — Rapid Aortic Measurements2025-09-23
K251533 — Rapid Obstructive Hydrocephalus, Rapid OH2025-09-04
K252526 — Rapid DeltaFuse2025-08-26
K243378 — Rapid MLS2025-05-28
K243350 — Rapid Neuro3D2025-01-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.