510(k) Report

Devices descending from K090238

46 later devices reach Sedecal X-Plus LP Plus Digital Diagnostic X-Ray Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150506ELIAN Digital Diagnostic X-ray SystemOsko, Inc.20150—
+1K132294Galaxy and Galaxy+Plus Digital Radiography SystemsRadiology Solutions, LLC20131—
+1K102408Digital Diagnostic X-Ray SystemDRGEM Corporation201017—
+1K092830Digital X-Ray Imaging System, Model DRC-1000VATECH Co., Ltd.201018—
+1K093688Canon, Model Urs-50RFVirtual Imaging, Inc.20105—
+2K192453Diamond-5A/6A/8ADRGEM Corporation20192—
+2K192364GXR-Series Diagnostic X-Ray SystemDRGEM Corporation201911—
+2K141743Fusion Digital Diagnostic X-Ray Upgrade KitRadiology Solutions, LLC20140—
+2K132921Galaxy PlusMedien International Co, Ltd.20140—
+2K123105Xgeo GU60Samsung Electronics Co., Ltd.20130—
+2K121303Mobile C-ArmCanon Inc. -Medical Equipment Group20120—
+2K102529D2RF Digital Dynamic Remote SystemStephanix Radiological Systems201031
+2K091090Digital Flat Panel X-Ray Detector, Model Xmaru 1717E-Woo Technology201017—
+3K260482DRE DuoJpi Healthcare Co, Ltd.20260—
+3K230800Xvision-525, Horizon, HI-300, HI-500, Saturn-F PF32, Saturn-F PF40, Saturn-F PF50Gemss Healthcare CO., LTD.20230—
+3K213479D²RS and D²RS 9090Stephanix20211—
+3K202572GXR-Series Diagnostic X-Ray SystemDRGEM Corporation20208—
+3K202156Diamond-5A/6A/8ADRGEM Corporation20201—
+3K150306D2RS_AT Digital Dynamic Remote SystemStephanix Radiological Solutions20150—
+3K142475EVS 4343DRTECH Corporation201513—
+3K122173Digital Flat Planel X-Ray Detector / 1717SCCRayence Co., Ltd.20120—
+3K122182Digital Flat Panel X-Ray Detector/1717SGCRayence Co., Ltd.20121—
+4K242019GXR-Series Diagnostic X-Ray SystemDRGEM Corporation20250—
+4K242119Innovision-ExiiDk Medical System20252—
+4K233530EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS…DRTECH Corporation20242—
+4K232178GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)DRGEM Corporation20230—
+4K221335D²RS and D²RS 9090Stephanix20220—
+4K220271Hand Diagnostic Radiography Imaging SystemNanoray Biotech Co., Ltd.20220—
+4K162555Evs 4343, Evs 4343GDRTECH Corporation20167—
+4K151942EVS 3643DRTECH Corporation20154—
+4K140646Digital Flat Panel X-Ray Detector / 1717G, XMARU1717GRayence Co., Ltd.20140—
+5K253446AeroDR TX c02Dk Medical Systems Co., Ltd.20260—
+5K250790Innovision-DxiiDk Medical Systems Co., Ltd.20250—
+5K242847EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS…DRTECH Corporation20241—
+5K192400Evs 4343A, Evs 4343AG, Evs 3643A, Evs 3643AGDRTECH Corporation20196—
+5K162552Evs 3643, Evs 3643GDRTECH Corporation20163—
+6K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS…DRTECH Corporation20260—
+6K232753Expd 4343D; Expd 3643DDRTECH Corporation20230—
+6K223124Expd 86P, Expd 86PG, Expd 129P, Expd 129PGDRTECH Corporation20222—
+6K193017Evs 4343W / Evs 4343WG / Evs 4343WP / Evs 3643W / Evs 3643WG / Evs 3643WPDRTECH Corporation20191—
+6K193031Expd 4343P, Expd 3643PDRTECH Corporation20191—
+6K171137Evs 2430W, Evs 2430GWDRTECH Corporation20170—
+7K242770Expd 114; Expd 114G; Expd 114P; Expd 114PGDRTECH Corporation20250—
+7K243443Expd 4343N1; Expd 4343N; Expd 4343U1; Expd 4343NU; Expd 4343NP; Expd 3643N1; Expd 3643N…DRTECH Corporation20250—
+7K232082EXPD 4343SDRTECH Corporation20240—
+7K231959Expd 4357; Expd 4357PDRTECH Corporation20230—