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

K250660

LUMINOS Q.namix T; LUMINOS Q.namix R

510(k) number
K250660
Device name
LUMINOS Q.namix T; LUMINOS Q.namix R
Applicant
Siemens Medical Solutions PA · US
Product code
OWB — Interventional Fluoroscopic X-Ray System
Decision date
2025-07-14
Date received
2025-03-05
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Radiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain

Also available from FDA: K250660.pdf

Official FDA record: K250660
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.