510(k) Report

Devices descending from K080064

69 later devices reach Flaatz 750 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113812ATAL-8Atlaim201241—
+1K113855Panorad, Panorad SLImix Adr Finland OY20120—
+1K111655Flaatz 760Drtech Corp.20110—
+1K102474Flaatz 750EDrtech Corp.20110—
+1K102284Krystalrad 560 (Flaatz 560)Medicatech USA20113—
+1K102285Krystalrad (ATAL8)Medicatech USA20110—
+1K083640Digital X-Ray Imaging System, Model: CXD-DR80DChoong Wae Medical Corp.20092—
+1K080582Medicatech, Model DDR Mak-800, DDT Mak-1000 FS, DDR Mak-1100 FAMedicatech USA200816—
+2K172435Galaxy R Digital Radiography UpgradeMedien International Co, Ltd.20170—
+2K160143ClearVision ExamVue Flat Panel DetectorJpi Healthcare, Inc.20161—
+2K152151ATAL 9Atlaim Corporation20155—
+2K123644Vizion + DRViztek, LLC201333—
+2K102327Clearvision DR 7000FJpi Healthcare Co, Ltd.20120—
+2K112132Krystalrad 660 Digital Radiographic Portable Retrofit SystemMedicatech USA201114—
+2K111583Flaatz 560Drtech Corp.20112—
+2K101779Clearvision DR 2000 Digital Radiography X-Ray SystemJpi Healthcare Co, Ltd.20110—
+2K082798Digital Diagnostic X-Ray System, Models Mak 1500, Mak 2000 and Mak 3000Medicatech USA20080—
+3K244010ExamVue ApexJpi Healthcare Co, Ltd.20250—
+3K180976PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor PanelsPixxgen Corporation20182—
+3K170480Models 3543A, 4343A, 2929A and A843BShanghai PZ Medical Technolgoy Co., Ltd.20171—
+3K170975Televere Digital Imaging SystemTelevere Systems20172—
+3K152279ViZion DR + WirelessViztek, LLC201527—
+3K141435Opal Chiro, 20/20 P-DR2020 Imaging20140—
+3K133139Vizion UltraViztek, LLC20140—
+3K132842Flaatz 600 Series (Flaatz 600/601)Drtech Corp.20140—
+3K130377Krystalrad New Seriesdigital Radiographic Portable Retrofit SystemMedicatech USA20131—
+3K130883Sedecal Digital Radiographic Upgrade Model Sdru-TSedecal., Sa.201311—
+4K230918MasterX 800 SeriesMedicatech USA20230—
+4K2121056543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZFPzmedical Technology Co., Ltd.20210—
+4K211542Primo SA.T.S. Applicazione Tecnologie Speciali S.R.L.20210—
+4K193644E-Com DR-2000 DRLivermoretech, Inc.20201—
+4K182533PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor PanelsPixxgen Corporation20181—
+4K180765Televere Podiatry X-Ray System HFTelevere Systems, Inc.20180—
+4K172124Televere Podiatry Digital Imaging SystemTelevere Systems20170—
+4K162529DigiX FDXAllengers Medical Systems Limited20176—
+4K161730Wireless Digital Flat Panel DetectorIray Technology (Shanghai), Ltd.201624—
+4K160810ViZion DR + WirelessViztek, LLC20161—
+4K140825Delworks DR SystemDel Medical, Inc.20147—
+5K211108Prudent 1717, Prudent 1417, Prudent 1212Pixxgen Corporation20210—
+5K203703I-Q ViewFirst Source, Inc.20210—
+5K202995X-ray Flat Panel Detectors/CareView 3600RFCareray Digital Medical System Co., Ltd.20210—
+5K192541DigiX FDXAllengers Medical Systems Limited20195—
+5K191645SKR 4000Konica Minolta, Inc.20190—
+5K182551Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.201818—
+5K182550Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.201812
+6K223060DigiX FDXAllengers Medical Systems Limited20224—
+6K201004Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat…Iray Technology Taicang, Ltd.20204—
+6K192512Focus 35C Detector, Trimax 35C DetectorIray Technology Taicang, Ltd.20190—
+6K190300BIOK7600W Wireless Flat Panel DetectorBiokinemetrics, Inc.20190—
+6K190311BIOK7600 Flat Panel DetectorBiokinemetrics, Inc.20190—
+6K183422Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20190—
+6K183713Wireless Digital Flat DetectorIray Technology Taicang, Ltd.20199—
+7K230985Planmeca VisoPlanmeca Oy20233—
+7K210316Mars 1417X Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20213—
+7K201043Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)Iray Technology Taicang, Ltd.20207—
+7K200622Focus 43C detector, TRIMAX 43C detectorIray Technology Taicang, Ltd.20200—
+8K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+8K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+8K221714Flat Panel DetectorIray Technology Taicang, Ltd.20221—
+8K220668Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20221—
+8K213646Focus HD 35 DetectorIray Technology Taicang, Ltd.20220—
+8K210314Mars1717X Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20214—
+9K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+9K222886Mercu 1717VIray Technology Taicang, Ltd.20220—
+9K221345Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20220—
+9K213529Focus HD 43 DetectorIray Technology Taicang, Ltd.20223—
+10K243556Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)Iray Imaging Technology (Haining) Limited20252—
+11K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…Carestream Health20260—
+11K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) Limited20250—