510(k) K250660

LUMINOS Q.namix T; LUMINOS Q.namix R by Siemens Medical Solutions — Product Code OWB

K250660 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions for the device "LUMINOS Q.namix T; LUMINOS Q.namix R". The FDA issued a decision of Substantially Equivalent on July 14, 2025. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650. Siemens Medical Solutions has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2025
Date Received
March 5, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Interventional Fluoroscopic X-Ray System
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Interventional fluoroscopy