DeviceClearance

Rapid ICH (v4.0)— 510(k) K262301

Substantially Equivalent

Ischemaview, Inc.

FDA 510(k) clearance K262301 for Rapid ICH (v4.0), Substantially Equivalent on 2026-10-09. Applicant: Ischemaview, Inc.. Device class: 2.

Summary

Rapid ICH (v4.0) from Ischemaview is filed under QAS, radiological computer-assisted triage and notification software. The record doesn't describe the software beyond its name and that code name.

Class II, 21 CFR 892.2080. The Radiology panel reviewed it as a Traditional 510(k).

Ischemaview filed from Golden, Colorado. Review took 94 days (July 7 to October 9, 2026).

Clearance details

Applicant
Ischemaview, Inc.
Product code
Product code QAS
Device class
Class 2
Regulation
21 CFR 892.2080
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Golden, CO, US
Download summary PDFView on FDA.gov ↗

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