Rapid Platform (R6.7)— 510(k) K261368

Name: FDA 510(k) clearance K261368
Creator: U.S. Food and Drug Administration
Published: 2026-09-21

Substantially Equivalent

Ischemaview, Inc.

FDA 510(k) clearance K261368 for Rapid Platform (R6.7), Substantially Equivalent on 2026-09-21. Applicant: Ischemaview, Inc.. Device class: 2.

Summary

Rapid Platform (R6.7) from Ischemaview, Inc. is filed under QIH, automated radiological image processing software. "R6.7" reads as a release number. The record doesn't describe which modules or analyses this release covers.

Class II, 21 CFR 892.2050. The Radiology panel reviewed it as a Traditional 510(k).

The company filed from Golden, Colorado. Review took 147 days (April 27 to September 21, 2026).

Clearance details

Applicant: Ischemaview, Inc.
Product code: Product code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2026-04-27
Decision date: 2026-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIH

view all

K261733 — Ligence Heart2026-10-07
K262134 — NeuroDR2026-10-07
K260523 — QGuideCT (1.0)2026-10-05
K260055 — syngo.CT Brain Quantification2026-09-25
K262390 — BoneXpert2026-09-22

More clearances from Ischemaview, Inc.

view all

K262301 — Rapid ICH (v4.0)2026-10-09
K251987 — Rapid Aortic Measurements2025-09-23
K251533 — Rapid Obstructive Hydrocephalus, Rapid OH2025-09-04
K252526 — Rapid DeltaFuse2025-08-26
K243378 — Rapid MLS2025-05-28

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