Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

K242166

TribusConnect

510(k) number
K242166
Device name
TribusConnect
Applicant
Tribusmed Beheer BV NL
Product code
QIH — Automated Radiological Image Processing Software
Decision date
2025-03-31
Date received
2024-07-24
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain

Also available from FDA: K242166.pdf

Official FDA record: K242166
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.