K261085

Rapid Vessel Occlusion (Rapid VO)

510(k) number
K261085
Device name
Rapid Vessel Occlusion (Rapid VO)
Applicant
iSchemaview CO · US
Product code
QAS — Radiological Computer-Assisted Triage And Notificati
Decision date
2026-07-13
Date received
2026-04-01
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Radiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain

Also available from FDA: K261085.pdf

Official FDA record: K261085
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.