510(k) Report

Devices descending from K082604

41 later devices reach Viztek DR, Models: DR1000, DR3000, DR4000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193225KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System…Konica Minolta Healthcare Americas, Inc.20202—
+1K102123Vizion DRViztek, Inc.201136—
+1K091752Viztek WLViztek, Inc.20090—
+2K214012Straight Arm DDRKonica Minolta Healthcare Americas, Inc.20221—
+2K112661Vizion DRViztek, LLC201134—
+2K111098Innovaxion FP, Innovaxion FP 1600 Plus, MagellanImaging Dynamics Company, Ltd.20110—
+3K221853Otc DDRKonica Minolta Healthcare Americas, Inc.20220—
+3K133139Vizion UltraViztek, LLC20140—
+3K123644Vizion + DRViztek, LLC201333—
+4K170975Televere Digital Imaging SystemTelevere Systems20172—
+4K152279ViZion DR + WirelessViztek, LLC201527—
+4K141435Opal Chiro, 20/20 P-DR2020 Imaging20140—
+5K180765Televere Podiatry X-Ray System HFTelevere Systems, Inc.20180—
+5K172124Televere Podiatry Digital Imaging SystemTelevere Systems20170—
+5K161730Wireless Digital Flat Panel DetectorIray Technology (Shanghai), Ltd.201624—
+5K160810ViZion DR + WirelessViztek, LLC20161—
+6K202995X-ray Flat Panel Detectors/CareView 3600RFCareray Digital Medical System Co., Ltd.20210—
+6K191645SKR 4000Konica Minolta, Inc.20190—
+6K182551Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.201818—
+6K182550Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.201812
+6K170480Models 3543A, 4343A, 2929A and A843BShanghai PZ Medical Technolgoy Co., Ltd.20171—
+7K2121056543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZFPzmedical Technology Co., Ltd.20210—
+7K201004Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat…Iray Technology Taicang, Ltd.20204—
+7K192512Focus 35C Detector, Trimax 35C DetectorIray Technology Taicang, Ltd.20190—
+7K190300BIOK7600W Wireless Flat Panel DetectorBiokinemetrics, Inc.20190—
+7K190311BIOK7600 Flat Panel DetectorBiokinemetrics, Inc.20190—
+7K183422Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20190—
+7K183713Wireless Digital Flat DetectorIray Technology Taicang, Ltd.20199—
+8K210316Mars 1417X Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20213—
+8K201043Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)Iray Technology Taicang, Ltd.20207—
+8K200622Focus 43C detector, TRIMAX 43C detectorIray Technology Taicang, Ltd.20200—
+9K221714Flat Panel DetectorIray Technology Taicang, Ltd.20221—
+9K220668Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20221—
+9K213646Focus HD 35 DetectorIray Technology Taicang, Ltd.20220—
+9K210314Mars1717X Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20214—
+10K222886Mercu 1717VIray Technology Taicang, Ltd.20220—
+10K221345Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20220—
+10K213529Focus HD 43 DetectorIray Technology Taicang, Ltd.20223—
+11K243556Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)Iray Imaging Technology (Haining) Limited20252—
+12K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…Carestream Health20260—
+12K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) Limited20250—