Cleared Traditional

LUMINOS Q.namix T; LUMINOS Q.namix R

K250660 · Siemens Medical Solutions · Radiology

Jul 2025

Decision

131d

Days

Class 2

Risk

About This 510(k) Submission

K250660 is an FDA 510(k) clearance for the LUMINOS Q.namix T; LUMINOS Q.namix R, a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by Siemens Medical Solutions (Malvern, US). The FDA issued a Cleared decision on July 14, 2025, 131 days after receiving the submission on March 5, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K250660 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 05, 2025
Decision Date	July 14, 2025
Days to Decision	131 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	OWB — Interventional Fluoroscopic X-ray System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.1650
Definition	Interventional Fluoroscopy