K240612

CINA-VCF

510(k) number
K240612
Device name
CINA-VCF
Applicant
Avicenna.Ai FR
Product code
QFM — Radiological Computer-Assisted Prioritization Softwa
Decision date
2024-05-31
Date received
2024-03-05
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Radiology
PDFDownload 510(k) SummaryArchived here · 1.9 MB · U.S. public domain

Also available from FDA: K240612.pdf

Official FDA record: K240612
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.