LUMINOS Q.namix T; LUMINOS Q.namix R

The LUMINOS Q.namix T and Q.namix R are multifunctional radiography/fluoroscopy (R/F) systems designed to visualize anatomical structures by converting X-ray patterns into visible images. Both are suitable for routine examinations including gastrointestinal, urogenital, arthrography, angiography, and pediatric applications, but are not intended for mammography. The Q.namix T is an under-table system while the Q.namix R is an over-table system.

The subject devices use the same OPTITOP X-ray tube as the predicate but incorporate a new Polydoros RFX generator (versus F80 in predicate), a new Digital Multileaf Collimator RFU, updated detectors (Pixium 4343F-5 X.fluoro and new Pixium models X.wi-D series), touchscreen interfaces in landscape format, myExam IQ image processing software with AI-based auto-cropping, and new optional features like wireless footswitches and flat tabletops. DSA functionality was removed from the subject devices.

The devices were tested against IEC/ISO standards including IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), IEC 60601-1-3 (radiation protection), IEC 60601-2-28 (X-ray tubes), IEC 60601-2-54 (radiography/fluoroscopy equipment), IEC 62304 (software lifecycle), ISO 14971 (risk management), and IEC 62366-1 (usability engineering).

The subject devices are substantially equivalent because they maintain the same fundamental technology and scientific principles as the predicates (Luminos Agile Max and Luminos dRF Max), use identical X-ray tubes and air kerma measurement methods, retain the same clinical indications and patient types, and employ components cleared in predicate systems or reference devices. Although component updates and new features were added (generator, detectors, software, user interface), these represent evolutionary improvements in state-of-the-art technology rather than changes to fundamental scientific technology, and clinical evaluations confirmed diagnostic image quality remains acceptable.