K243145

syngo.CT LVO Detection

510(k) number
K243145
Device name
syngo.CT LVO Detection
Applicant
Siemens Medical Solutions USA, Inc. TN · US
Product code
QAS — Radiological Computer-Assisted Triage And Notificati
Decision date
2025-04-10
Date received
2024-09-30
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain

Also available from FDA: K243145.pdf

Official FDA record: K243145
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.