Diagnostic X-ray System

The Diagnostic X-ray System (PLX119C) is a mobile fluoroscopic C-arm system that generates X-ray images for real-time radiological guidance during diagnostic, interventional, and surgical procedures. It consists of an X-ray tube, flat-panel detector, image processing workstation, and C-arm apparatus, and is intended for use by trained healthcare professionals on all patients except neonates in various healthcare settings.

The proposed device uses a fixed anode X-ray tube (15° angle, 0.6/1.8 mm focal size) operating at 40–120 kV, whereas the predicate uses a rotating anode (10° angle, 0.3/0.6 mm focal size) at 40–125 kV. The detector differs significantly: the proposed device incorporates a 12"×12" THALES Pixium3030S detector (1956×1956 pixel matrix, 154 μm pitch), while the predicate uses a 9"×9" IRAY Mercu 0909F detector (1024×1024 pixels, 205 μm pitch). Both systems use amorphous silicon detectors with cesium iodide scintillators and achieve comparable performance metrics (MTF ~59–64%, DQE ~77%). C-arm mechanics, collimator control, and fluoroscopic modes (pulse, ABS function) are equivalent.

IEC 60601-1-2:2014+AMD1:2020 (electrical safety and EMC), IEC 60601-2-54:2009+A2:2019 (diagnostic X-ray equipment), IEC 60601-1-3:2008+A2:2021 (radiation protection), IEC 60601-2-43:2010+A2:2020 (interventional equipment), IEC 60601-1-6 (usability), IEC 62366-1 (usability engineering), and ISO 10993-1:2018 (biocompatibility). Bench testing of detector imaging metrics and clinical image assessment by a qualified radiologist were performed.

The proposed device shares identical indications for use, operational principles, and primary functionality with the predicate—both are mobile fluoroscopic C-arm systems for real-time image guidance in diagnostic, interventional, and surgical procedures. Although the proposed device uses a larger fixed-anode detector (12" vs. 9") with higher pixel resolution, and operates at slightly lower maximum kV (120 vs. 125), both achieve comparable imaging performance (MTF and DQE metrics are equivalent or very similar). The differences in anode type and detector size do not introduce new safety or effectiveness concerns; bench testing and clinical image review confirmed acceptable imaging performance equivalent to the predicate. All other system components, software controls, and safety compliance measures are substantially similar.