510(k) Report

Devices descending from K012546

158 later devices reach Optima Urs Universal Radiographic System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K170975Televere Digital Imaging SystemTelevere Systems20172—
+6K163410DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Ltd.201714
+6K162555Evs 4343, Evs 4343GDRTECH Corporation20167—
+6K151942EVS 3643DRTECH Corporation20154—
+6K152279ViZion DR + WirelessViztek, LLC201527—
+6K141435Opal Chiro, 20/20 P-DR2020 Imaging20140—
+6K140646Digital Flat Panel X-Ray Detector / 1717G, XMARU1717GRayence Co., Ltd.20140—
+7K253446AeroDR TX c02Dk Medical Systems Co., Ltd.20260—
+7K252649TAP2DNano-X Imaging, Ltd.20260—
+7K250790Innovision-DxiiDk Medical Systems Co., Ltd.20250—
+7K242847EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS…DRTECH Corporation20241—
+7K223060DigiX FDXAllengers Medical Systems Limited20224—
+7K201725DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Lit.202003
+7K192400Evs 4343A, Evs 4343AG, Evs 3643A, Evs 3643AGDRTECH Corporation20196—
+7K180765Televere Podiatry X-Ray System HFTelevere Systems, Inc.20180—
+7K172124Televere Podiatry Digital Imaging SystemTelevere Systems20170—
+7K161730Wireless Digital Flat Panel DetectorIray Technology (Shanghai), Ltd.201624—
+7K162552Evs 3643, Evs 3643GDRTECH Corporation20163—
+7K160810ViZion DR + WirelessViztek, LLC20161—
+8K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS…DRTECH Corporation20260—
+8K230985Planmeca VisoPlanmeca Oy20233—
+8K232753Expd 4343D; Expd 3643DDRTECH Corporation20230—
+8K223124Expd 86P, Expd 86PG, Expd 129P, Expd 129PGDRTECH Corporation20222—
+8K202995X-ray Flat Panel Detectors/CareView 3600RFCareray Digital Medical System Co., Ltd.20210—
+8K193017Evs 4343W / Evs 4343WG / Evs 4343WP / Evs 3643W / Evs 3643WG / Evs 3643WPDRTECH Corporation20191—
+8K193031Expd 4343P, Expd 3643PDRTECH Corporation20191—
+8K191645SKR 4000Konica Minolta, Inc.20190—
+8K182551Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.201818—
+8K182550Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.201812
+8K170480Models 3543A, 4343A, 2929A and A843BShanghai PZ Medical Technolgoy Co., Ltd.20171—
+8K171137Evs 2430W, Evs 2430GWDRTECH Corporation20170—
+9K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+9K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+9K242770Expd 114; Expd 114G; Expd 114P; Expd 114PGDRTECH Corporation20250—
+9K243443Expd 4343N1; Expd 4343N; Expd 4343U1; Expd 4343NU; Expd 4343NP; Expd 3643N1; Expd 3643N…DRTECH Corporation20250—
+9K232082EXPD 4343SDRTECH Corporation20240—
+9K231959Expd 4357; Expd 4357PDRTECH Corporation20230—
+9K2121056543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZFPzmedical Technology Co., Ltd.20210—
+9K201004Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat…Iray Technology Taicang, Ltd.20204—
+9K192512Focus 35C Detector, Trimax 35C DetectorIray Technology Taicang, Ltd.20190—
+9K190300BIOK7600W Wireless Flat Panel DetectorBiokinemetrics, Inc.20190—
+9K190311BIOK7600 Flat Panel DetectorBiokinemetrics, Inc.20190—
+9K183422Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20190—
+9K183713Wireless Digital Flat DetectorIray Technology Taicang, Ltd.20199—
+10K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+10K210316Mars 1417X Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20213—
+10K201043Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)Iray Technology Taicang, Ltd.20207—
+10K200622Focus 43C detector, TRIMAX 43C detectorIray Technology Taicang, Ltd.20200—
+11K221714Flat Panel DetectorIray Technology Taicang, Ltd.20221—
+11K220668Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20221—
+11K213646Focus HD 35 DetectorIray Technology Taicang, Ltd.20220—
+11K210314Mars1717X Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20214—
+12K222886Mercu 1717VIray Technology Taicang, Ltd.20220—
+12K221345Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20220—
+12K213529Focus HD 43 DetectorIray Technology Taicang, Ltd.20223—
+13K243556Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)Iray Imaging Technology (Haining) Limited20252—
+14K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…Carestream Health20260—
+14K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) Limited20250—