510(k) Report

Devices descending from K003438

64 later devices reach Smart Rad through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100400Prestodr PortableCmt Medical Technologies, Ltd.20103—
+1K091631Accessnet, Accessmed, Accessrad, MedviewAspyra, Inc.20100—
+1K091752Viztek WLViztek, Inc.20090—
+1K083224Cpi Rad Vision, Model VZW2944XX-YYCommunications & Power Industries Canada, Inc.200916—
+1K082604Viztek DR, Models: DR1000, DR3000, DR4000Viztek, Inc.200841—
+2K193225KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System…Konica Minolta Healthcare Americas, Inc.20202—
+2K131314Ddrcruze (Digital Mobile Diagnostic X-Ray System)Swissray Medical AG20130—
+2K110849Prestodr 4143Cmt Medical Technologies, Ltd.20111—
+2K102123Vizion DRViztek, Inc.201136—
+2K101042BladeviewAccogent, LLC20100—
+2K100449Minxray Model CMDR-2SMinxray, Inc.201014—
+3K214012Straight Arm DDRKonica Minolta Healthcare Americas, Inc.20221—
+3K162224ArtPix Mobile EZ2GOCmt Medical Technologies, Ltd.20160—
+3K141885CMDR-2ST & CMDR-2SLWT Digital Portable X-RayMinxray, Inc.201413—
+3K112661Vizion DRViztek, LLC201134—
+3K111098Innovaxion FP, Innovaxion FP 1600 Plus, MagellanImaging Dynamics Company, Ltd.20110—
+4K221853Otc DDRKonica Minolta Healthcare Americas, Inc.20220—
+4K171353CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), IntegrisMinxray, Inc.201712—
+4K133139Vizion UltraViztek, LLC20140—
+4K123644Vizion + DRViztek, LLC201333—
+5K191451CMDR 2CW (Multiple models)Minxray, Inc.201911—
+5K170975Televere Digital Imaging SystemTelevere Systems20172—
+5K152279ViZion DR + WirelessViztek, LLC201527—
+5K141435Opal Chiro, 20/20 P-DR2020 Imaging20140—
+6K201575CMDR 2C (Multiple Models)Minxray, Inc.20200—
+6K200726AcuityPDRRadmedix, LLC20209—
+6K180765Televere Podiatry X-Ray System HFTelevere Systems, Inc.20180—
+6K172124Televere Podiatry Digital Imaging SystemTelevere Systems20170—
+6K161730Wireless Digital Flat Panel DetectorIray Technology (Shanghai), Ltd.201624—
+6K160810ViZion DR + WirelessViztek, LLC20161—
+7K202995X-ray Flat Panel Detectors/CareView 3600RFCareray Digital Medical System Co., Ltd.20210—
+7K202350SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+7K202353SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20202—
+7K201058Accuvue+Radmedix, LLC20204—
+7K191645SKR 4000Konica Minolta, Inc.20190—
+7K182551Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.201818—
+7K182550Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.201812
+7K170480Models 3543A, 4343A, 2929A and A843BShanghai PZ Medical Technolgoy Co., Ltd.20171—
+8K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.20260—
+8K240841Digital Radiography System (ManntiX B, ManntiX K)Shenzhen Browiner Tech Co., Ltd.20240—
+8K2121056543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZFPzmedical Technology Co., Ltd.20210—
+8K210919AcuityDReRadmedix, LLC20213—
+8K201004Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat…Iray Technology Taicang, Ltd.20204—
+8K192512Focus 35C Detector, Trimax 35C DetectorIray Technology Taicang, Ltd.20190—
+8K190300BIOK7600W Wireless Flat Panel DetectorBiokinemetrics, Inc.20190—
+8K190311BIOK7600 Flat Panel DetectorBiokinemetrics, Inc.20190—
+8K183422Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20190—
+8K183713Wireless Digital Flat DetectorIray Technology Taicang, Ltd.20199—
+9K231709AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4Radmedix, LLC20230—
+9K214030Universal DR 1748Konica Minolta Healthcare Americas, Inc.20221—
+9K210316Mars 1417X Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20213—
+9K201043Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)Iray Technology Taicang, Ltd.20207—
+9K200622Focus 43C detector, TRIMAX 43C detectorIray Technology Taicang, Ltd.20200—
+10K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.20260—
+10K221714Flat Panel DetectorIray Technology Taicang, Ltd.20221—
+10K220668Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20221—
+10K213646Focus HD 35 DetectorIray Technology Taicang, Ltd.20220—
+10K210314Mars1717X Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20214—
+11K222886Mercu 1717VIray Technology Taicang, Ltd.20220—
+11K221345Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20220—
+11K213529Focus HD 43 DetectorIray Technology Taicang, Ltd.20223—
+12K243556Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)Iray Imaging Technology (Haining) Limited20252—
+13K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…Carestream Health20260—
+13K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) Limited20250—