510(k) Report

Devices descending from K062335

99 later devices reach Sedecal X Plus LP Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103050DX-D 300Agfa Healthcare N.V.20108—
+1K090279Sedecal, Millennium PlusSedecal., Sa.200917—
+1K090238Sedecal X-Plus LP Plus Digital Diagnostic X-Ray SystemsSedecal., Sa.200946—
+1K080582Medicatech, Model DDR Mak-800, DDT Mak-1000 FS, DDR Mak-1100 FAMedicatech USA200816—
+1K063283Definium 5000 X-Ray SystemSedecal., Sa.2006143
+2K203537Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic SystemsSedecal., Sa.20210—
+2K182134ARiX RAD Radiographic SystemCompania Mexicana DE Radiologia Cgr, S.A. DE C.V.20181—
+2K150506ELIAN Digital Diagnostic X-ray SystemOsko, Inc.20150—
+2K133782Nova FA DR SystemSedecal., Sa.2014111
+2K132294Galaxy and Galaxy+Plus Digital Radiography SystemsRadiology Solutions, LLC20131—
+2K122495Perkinelmer XRD 1622 AP3 Med Flat Panel DetectorPerkinelmer, Inc.201213—
+2K121345SR Suite 1.0Halifax Biomedical, Inc.20121—
+2K112132Krystalrad 660 Digital Radiographic Portable Retrofit SystemMedicatech USA201114—
+2K112670DX-D 600Agfa Healthcare N.V.201174
+2K102408Digital Diagnostic X-Ray SystemDRGEM Corporation201017—
+2K092830Digital X-Ray Imaging System, Model DRC-1000VATECH Co., Ltd.201018—
+2K093688Canon, Model Urs-50RFVirtual Imaging, Inc.20105—
+2K082798Digital Diagnostic X-Ray System, Models Mak 1500, Mak 2000 and Mak 3000Medicatech USA20080—
+3K202388Apolo D / Apolo SVmi Tecnologias Ltda20200—
+3K202293Radiographic System Challenge XSedecal., Sa.20200—
+3K193637MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic SystemCompania Mexicana DE Radiologia Cgr, S.A. DE C.V.20200—
+3K192453Diamond-5A/6A/8ADRGEM Corporation20192—
+3K192364GXR-Series Diagnostic X-Ray SystemDRGEM Corporation201911—
+3K182880Halifax Imaging KitHalifax Biomedical, Inc.20180—
+3K173953uDR 780iShanghai United Imaging Healthcare Co., Ltd.20182—
+3K152639DR 600Agfa Healthcare N.V.20156—
+3K150816Jumong SeriesSg Healthcare Co, Ltd.20152—
+3K143257KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic SystemMedicatech USA20152—
+3K141743Fusion Digital Diagnostic X-Ray Upgrade KitRadiology Solutions, LLC20140—
+3K140551Perkinelmer, Xrpad 4336 Med Flat Panel DetectorPerkinelmer, Inc.201412—
+3K132921Galaxy PlusMedien International Co, Ltd.20140—
+3K123105Xgeo GU60Samsung Electronics Co., Ltd.20130—
+3K130377Krystalrad New Seriesdigital Radiographic Portable Retrofit SystemMedicatech USA20131—
+3K130883Sedecal Digital Radiographic Upgrade Model Sdru-TSedecal., Sa.201311—
+3K121303Mobile C-ArmCanon Inc. -Medical Equipment Group20120—
+3K102529D2RF Digital Dynamic Remote SystemStephanix Radiological Systems201031
+3K091090Digital Flat Panel X-Ray Detector, Model Xmaru 1717E-Woo Technology201017—
+4K260482DRE DuoJpi Healthcare Co, Ltd.20260—
+4K241068uDR 780iShanghai United Imaging Healthcare Co., Ltd.20241—
+4K230800Xvision-525, Horizon, HI-300, HI-500, Saturn-F PF32, Saturn-F PF40, Saturn-F PF50Gemss Healthcare CO., LTD.20230—
+4K230918MasterX 800 SeriesMedicatech USA20230—
+4K230241Jumong GeneralSg Healthcare Co, Ltd.20230—
+4K213479D²RS and D²RS 9090Stephanix20211—
+4K213469ValoryAgfa N.V.20210—
+4K211542Primo SA.T.S. Applicazione Tecnologie Speciali S.R.L.20210—
+4K202572GXR-Series Diagnostic X-Ray SystemDRGEM Corporation20208—
+4K202156Diamond-5A/6A/8ADRGEM Corporation20201—
+4K193262DR 600 with TomosynthesisAgfa N.V.20204—
+4K193644E-Com DR-2000 DRLivermoretech, Inc.20201—
+4K190601MasteRad MX30Medicatech USA20190—
+4K183541ProRad 2FC and ProRad 3NC Stationary Radiographic SystemsPrognosys Medical Systems Private Limited20190—
+4K162529DigiX FDXAllengers Medical Systems Limited20176—
+4K161966PerkinElmer XRpad2 4336 HWC-M Flat Panel DetectorPerkinelmer, Inc.20161—
+4K161942PerkinElmer, XRpad2 3025 HWC-M Flat Panel DetectorPerkinelmer, Inc.20160—
+4K150306D2RS_AT Digital Dynamic Remote SystemStephanix Radiological Solutions20150—
+4K151219Models 2200DR and 1600DR Digital Stationary Radiographic SystemsBeijing Polycon Medical Engineering Company20150—
+4K151221Kubtec DIGIVIEW 395Kub Technologies, Inc.20150—
+4K142475EVS 4343DRTECH Corporation201513—
+4K142698PerkinElmer, XRpad 4343 F MED Flat Panel DetectorPerkinelmer, Inc.20147—
+4K140825Delworks DR SystemDel Medical, Inc.20147—
+4K122173Digital Flat Planel X-Ray Detector / 1717SCCRayence Co., Ltd.20120—
+4K122182Digital Flat Panel X-Ray Detector/1717SGCRayence Co., Ltd.20121—
+5K251167uDR Aurora CXShanghai United Imaging Healthcare Co., Ltd.20250—
+5K242019GXR-Series Diagnostic X-Ray SystemDRGEM Corporation20250—
+5K242119Innovision-ExiiDk Medical System20252—
+5K233530EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS…DRTECH Corporation20242—
+5K232178GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)DRGEM Corporation20230—
+5K222934Nanox.ARCNano-X Imaging, Ltd.20233—
+5K221335D²RS and D²RS 9090Stephanix20220—
+5K220271Hand Diagnostic Radiography Imaging SystemNanoray Biotech Co., Ltd.20220—
+5K203703I-Q ViewFirst Source, Inc.20210—
+5K192541DigiX FDXAllengers Medical Systems Limited20195—
+5K181526XRpad2 4343 HWC-M Flat Panel DetectorVarex Imaging Corporation20180—
+5K162555Evs 4343, Evs 4343GDRTECH Corporation20167—
+5K151942EVS 3643DRTECH Corporation20154—
+5K140646Digital Flat Panel X-Ray Detector / 1717G, XMARU1717GRayence Co., Ltd.20140—
+6K253446AeroDR TX c02Dk Medical Systems Co., Ltd.20260—
+6K250790Innovision-DxiiDk Medical Systems Co., Ltd.20250—
+6K242395Nanox.ARCNano-X Imaging, Ltd.20242—
+6K242847EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS…DRTECH Corporation20241—
+6K223060DigiX FDXAllengers Medical Systems Limited20224—
+6K192400Evs 4343A, Evs 4343AG, Evs 3643A, Evs 3643AGDRTECH Corporation20196—
+6K162552Evs 3643, Evs 3643GDRTECH Corporation20163—
+7K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS…DRTECH Corporation20260—
+7K250850Nanox.ARC XNano-X Imaging, Ltd.20251—
+7K230985Planmeca VisoPlanmeca Oy20233—
+7K232753Expd 4343D; Expd 3643DDRTECH Corporation20230—
+7K223124Expd 86P, Expd 86PG, Expd 129P, Expd 129PGDRTECH Corporation20222—
+7K193017Evs 4343W / Evs 4343WG / Evs 4343WP / Evs 3643W / Evs 3643WG / Evs 3643WPDRTECH Corporation20191—
+7K193031Expd 4343P, Expd 3643PDRTECH Corporation20191—
+7K171137Evs 2430W, Evs 2430GWDRTECH Corporation20170—
+8K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+8K252649TAP2DNano-X Imaging, Ltd.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—
+9K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—