Rapid Vessel Occlusion (Rapid VO)— 510(k) K261085

Substantially Equivalent

iSchemaview

FDA 510(k) clearance K261085 for Rapid Vessel Occlusion (Rapid VO), Substantially Equivalent on 2026-07-13. Applicant: iSchemaview. Device class: 2.

Clearance details

Applicant: iSchemaview
Product code: Code QAS
Device class: Class 2
Regulation: 21 CFR 892.2080
Advisory panel: Radiology
Date received: 2026-04-01
Decision date: 2026-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden, CO, US

Download summary PDF View on FDA.gov ↗

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