# K250660: LUMINOS Q.namix T; LUMINOS Q.namix R

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions
- Decided: Jul 14, 2025 after 131 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K801623 (1980). 62 ancestors in all.
No later device cites it as a predicate yet.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173639: Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax, Siemens Medi Cal Solutions, Inc. (2018) Summary page 6.

## Recalls of this device
- Dec 29, 2025 · Class II · Z-1174-2026: Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
- Dec 29, 2025 · Class II · Z-1175-2026: Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.

## Indications for use
LUMINOS Q.namix T and LUMINOS Q.namix R are devices intended to visualize anatomical structures by converting an X-ray pattern into a visible image. It is a multifunctional, general R/F system, suitable for routine radiography and fluoroscopy examinations, including gastrointestinal- and urogenital examinations and specialist areas like arthrography, angiography and pediatrics. LUMINOS Q.namix T and LUMINOS Q.namix R are not intended to be used for mammography examinations.

Source page: https://510kreport.com/device/K250660
Methodology: https://510kreport.com/methodology