510(k) Report

Devices descending from K201043

7 later devices reach Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221714Flat Panel DetectorIray Technology Taicang, Ltd.20221—
+1K210314Mars1717X Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20214—
+2K222886Mercu 1717VIray Technology Taicang, Ltd.20220—
+2K213529Focus HD 43 DetectorIray Technology Taicang, Ltd.20223—
+3K243556Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)Iray Imaging Technology (Haining) Limited20252—
+4K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…Carestream Health20260—
+4K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) Limited20250—