510(k) Report

Devices descending from K161730

24 later devices reach Wireless Digital Flat Panel Detector through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202995X-ray Flat Panel Detectors/CareView 3600RFCareray Digital Medical System Co., Ltd.20210—
+1K182551Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.201818—
+1K182550Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.201812
+1K170480Models 3543A, 4343A, 2929A and A843BShanghai PZ Medical Technolgoy Co., Ltd.20171—
+2K2121056543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZFPzmedical Technology Co., Ltd.20210—
+2K201004Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat…Iray Technology Taicang, Ltd.20204—
+2K192512Focus 35C Detector, Trimax 35C DetectorIray Technology Taicang, Ltd.20190—
+2K190300BIOK7600W Wireless Flat Panel DetectorBiokinemetrics, Inc.20190—
+2K190311BIOK7600 Flat Panel DetectorBiokinemetrics, Inc.20190—
+2K183422Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20190—
+2K183713Wireless Digital Flat DetectorIray Technology Taicang, Ltd.20199—
+3K210316Mars 1417X Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20213—
+3K201043Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)Iray Technology Taicang, Ltd.20207—
+3K200622Focus 43C detector, TRIMAX 43C detectorIray Technology Taicang, Ltd.20200—
+4K221714Flat Panel DetectorIray Technology Taicang, Ltd.20221—
+4K220668Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20221—
+4K213646Focus HD 35 DetectorIray Technology Taicang, Ltd.20220—
+4K210314Mars1717X Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20214—
+5K222886Mercu 1717VIray Technology Taicang, Ltd.20220—
+5K221345Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20220—
+5K213529Focus HD 43 DetectorIray Technology Taicang, Ltd.20223—
+6K243556Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)Iray Imaging Technology (Haining) Limited20252—
+7K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…Carestream Health20260—
+7K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) Limited20250—