K240724

SynthVISION 1.0.0

510(k) number
K240724
Device name
SynthVISION 1.0.0
Applicant
Synthesis Health Intelligence, Inc. CA
Product code
LLZ — System, Image Processing, Radiological
Decision date
2024-08-08
Date received
2024-03-18
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Radiology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain

Also available from FDA: K240724.pdf

Official FDA record: K240724
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.