510(k) Report

Devices descending from K042876

138 later devices reach Urs LP Digital, Millennium, Radpro through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K230985Planmeca VisoPlanmeca Oy20233—
+7K232753Expd 4343D; Expd 3643DDRTECH Corporation20230—
+7K223124Expd 86P, Expd 86PG, Expd 129P, Expd 129PGDRTECH Corporation20222—
+7K202995X-ray Flat Panel Detectors/CareView 3600RFCareray Digital Medical System Co., Ltd.20210—
+7K193017Evs 4343W / Evs 4343WG / Evs 4343WP / Evs 3643W / Evs 3643WG / Evs 3643WPDRTECH Corporation20191—
+7K193031Expd 4343P, Expd 3643PDRTECH Corporation20191—
+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—
+7K171137Evs 2430W, Evs 2430GWDRTECH Corporation20170—
+8K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+8K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+8K242770Expd 114; Expd 114G; Expd 114P; Expd 114PGDRTECH Corporation20250—
+8K243443Expd 4343N1; Expd 4343N; Expd 4343U1; Expd 4343NU; Expd 4343NP; Expd 3643N1; Expd 3643N…DRTECH Corporation20250—
+8K232082EXPD 4343SDRTECH Corporation20240—
+8K231959Expd 4357; Expd 4357PDRTECH Corporation20230—
+8K2121056543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZFPzmedical Technology Co., Ltd.20210—
+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—
+9K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+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—
+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—