510(k) Report

Devices descending from K113812

41 later devices reach ATAL-8 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172435Galaxy R Digital Radiography UpgradeMedien International Co, Ltd.20170—
+1K160143ClearVision ExamVue Flat Panel DetectorJpi Healthcare, Inc.20161—
+1K152151ATAL 9Atlaim Corporation20155—
+1K123644Vizion + DRViztek, LLC201333—
+2K244010ExamVue ApexJpi Healthcare Co, Ltd.20250—
+2K180976PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor PanelsPixxgen Corporation20182—
+2K170480Models 3543A, 4343A, 2929A and A843BShanghai PZ Medical Technolgoy Co., Ltd.20171—
+2K170975Televere Digital Imaging SystemTelevere Systems20172—
+2K152279ViZion DR + WirelessViztek, LLC201527—
+2K141435Opal Chiro, 20/20 P-DR2020 Imaging20140—
+2K133139Vizion UltraViztek, LLC20140—
+3K2121056543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZFPzmedical Technology Co., Ltd.20210—
+3K182533PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor PanelsPixxgen Corporation20181—
+3K180765Televere Podiatry X-Ray System HFTelevere Systems, Inc.20180—
+3K172124Televere Podiatry Digital Imaging SystemTelevere Systems20170—
+3K161730Wireless Digital Flat Panel DetectorIray Technology (Shanghai), Ltd.201624—
+3K160810ViZion DR + WirelessViztek, LLC20161—
+4K211108Prudent 1717, Prudent 1417, Prudent 1212Pixxgen Corporation20210—
+4K202995X-ray Flat Panel Detectors/CareView 3600RFCareray Digital Medical System Co., Ltd.20210—
+4K191645SKR 4000Konica Minolta, Inc.20190—
+4K182551Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.201818—
+4K182550Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.201812
+5K201004Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat…Iray Technology Taicang, Ltd.20204—
+5K192512Focus 35C Detector, Trimax 35C DetectorIray Technology Taicang, Ltd.20190—
+5K190300BIOK7600W Wireless Flat Panel DetectorBiokinemetrics, Inc.20190—
+5K190311BIOK7600 Flat Panel DetectorBiokinemetrics, Inc.20190—
+5K183422Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20190—
+5K183713Wireless Digital Flat DetectorIray Technology Taicang, Ltd.20199—
+6K210316Mars 1417X Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20213—
+6K201043Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)Iray Technology Taicang, Ltd.20207—
+6K200622Focus 43C detector, TRIMAX 43C detectorIray Technology Taicang, Ltd.20200—
+7K221714Flat Panel DetectorIray Technology Taicang, Ltd.20221—
+7K220668Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20221—
+7K213646Focus HD 35 DetectorIray Technology Taicang, Ltd.20220—
+7K210314Mars1717X Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20214—
+8K222886Mercu 1717VIray Technology Taicang, Ltd.20220—
+8K221345Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20220—
+8K213529Focus HD 43 DetectorIray Technology Taicang, Ltd.20223—
+9K243556Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)Iray Imaging Technology (Haining) Limited20252—
+10K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…Carestream Health20260—
+10K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) Limited20250—