510(k) Report

Devices descending from K843696

78 later devices reach Ophthalmic a-Scan a-2000 Sonome through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133132Optical Biometer AL-ScanNidek Co., Ltd.201401
+1K040668E-Z Scan AB5500+Sonomed, Inc.200476—
+2K140199VUPADSonomed, Inc.20144—
+2K100252Master-VU a-Scan, MV4500Sonomed, Inc.20100—
+2K063433Ultrasonic Biometer/Pachymeter for Opthalmology Odm 2100 and Odm 2200Meda, Ltd.20071—
+2K042467Lso Pet/CT Hirez 64Cti Pet Systems, Inc.2004671
+3K222787Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C…Chongqing Sunkingdom Medical Instrument Co., Ltd.20230—
+3K213070MD-320W Ultrasound BiomicroscopeMEDA Co., Ltd.20210—
+3K170761LIGHTSonic BUBMLightmed USA, Inc.20181—
+3K171301Scanmate FlexDgh Technology, Inc.20170—
+3K050509Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64ICti Pet Systems, Inc.200566—
+4K183173LIGHTMED Ultrasound SystemLightmed USA, Inc.20190—
+4K060631Biograph 64 and Biograph 40Siemens Medical Solutions USA, Inc.2006643
+4K060060Biograph 6Siemens Medical Solutions USA, Inc.200665—
+5K173547ImagenUniversalCardiovascular Imaging Technologies20180—
+5K083852Biograph 16 True Point SystemsSiemens Medical Solutions USA, Inc.20090—
+5K081453Biograph HD FamilySiemens Medical Solutions USA, Inc.200862—
+5K071068Biograph 6 Truepoint, Model Biograph 6 - P/N 10238197Siemens Medical Solutions USA, Inc.20070—
+6K103429Biograph MMRSiemens Medical Solutions USA, Inc.2011211
+6K101550Biograph MCT FamilySiemens Medical Solutions USA, Inc.201038—
+7K133226Biograph MMRSiemens Medical Solutions USA, Inc.2013201
+7K113448Biograph MCT FamilySiemens Medical Solutions USA, Inc.201137—
+8K163234Biograph mMR with syngo MR E11P system softwareSiemens Medical Solutions USA, Inc.201712—
+8K142098Signa Pet/MRGe Medical Systems, LLC201466
+8K123737Biograph MCT FamilySiemens Medical Solutions USA, Inc.20133617
+9K253963Cubresa BrainPETCubresa, Inc.20260—
+9K200213Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc.20201Class I
+9K183014uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20193—
+9K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+9K172531Biograph mMR with mMR Angio Transfer OptionSiemens Medical Solutions USA, Inc.20170—
+9K163619Signa Pet/MRGe Medical Systems, LLC201717
+9K151486Biograph mCT and mCT Flow PET/CT ScannersSiemens Medical Solutions USA, Inc.20153411
+9K141971Biograph True Pet/CT Family SoftwareSiemens Medical Solutions USA, Inc.2014037
+10K253023BIOGRAPH OneSiemens Healthineers AG20260—
+10K213709Signa Pet/MRGe Medical Systems, LLC202203
+10K192672uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20192—
+10K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+10K172143uMI 780 PET/CT SystemShanghai United Imaging Healthcare Co., Ltd.2018162
+10K173578Biograph mCT Family of PET/CT SystemsSiemens Medical Solutions USA, Inc.201792
+10K152880Biograph Horizon PET/CTSiemens Medical Solutions USA, Inc.201651
+11K241596uMI PanvivoShanghai United Imaging Healthcare Co., Ltd.202451
+11K223325uMI PanoramaShanghai United Imaging Healthcare Co., Ltd.202332
+11K222540uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20221—
+11K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+11K193210Hyper DLRShanghai United Imaging Healthcare Co., Ltd.20200—
+11K193248Biograph Vision, Biograph mCT Family of PET/CTsSiemens Medical Solutions USA, Inc.202062
+11K182938Emission Computed Tomography SystemShanghai United Imaging Healthcare Co., Ltd.201811
+11K182237uMI 550 PET/CT SystemShanghai United Imaging Healthcare Co., Ltd.2018310
+11K180811Biograph VisionSiemens Medical Solutions USA, Inc.20188—
+11K170904Biograph Horizon PET/CTSiemens Medical Solutions USA, Inc.201734
+11K162736Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CTSiemens Medical Solutions USA, Inc.20160—
+12K251671Biograph Vision PET/CT Systems; Biograph mCT PET/CT SystemsSiemens Medical Solutions USA, Inc.20250—
+12K243538uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)Shanghai United Imaging Healthcare Co., Ltd.202441
+12K234154uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20240—
+12K231762uEXPLORERShanghai United Imaging Healthcare Co., Ltd.202401
+12K233677Biograph VK10Siemens Medical Solutions USA, Inc.20241—
+12K232712uMI PanoramaShanghai United Imaging Healthcare Co., Ltd.202302
+12K231572uMI PanoramaShanghai United Imaging Healthcare Co., Ltd.202311
+12K231833Biograph Vision.X and Biograph Vision.X EdgeSiemens Medical Solutions USA, Inc.20230—
+12K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+12K210262Biograph Vision Quadra PET/CT SystemSiemens Medical Solutions USA, Inc.20211—
+12K193178Biograph HorizonSiemens Medical Solution USA, Inc.202021
+12K193241Emission Computed Tomography SystemShanghai United Imaging Healthcare Co., Ltd.202016
+12K190900Biograph VisionSiemens Medical Solutions USA, Inc.20197—
+13K253844AnyScan 3.0 NM Scanner FamilyMediso Medical Imaging Systems, Ltd.20250—
+13K251561Biograph TrinionSiemens Medical Solutions USA, Inc.20250—
+13K251839uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)Shanghai United Imaging Healthcare Co., Ltd.202532
+13K241585uMI PanoramaShanghai United Imaging Healthcare Co., Ltd.202401
+13K223547Biograph Vision Quadra PET/CT SystemSiemens Medical Solutions USA, Inc.20220—
+13K222895DynamicIQGE Medical Systems SCS20220—
+13K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+13K210001HYPER AiRShanghai United Imaging Healthcare Co., Ltd.20210—
+14K261427uMI Panvivo (uMI Panvivo M)Shanghai United Imaging Healthcare Co., Ltd.20260—
+14K253564uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX)…Shanghai United Imaging Healthcare Co., Ltd.20261—
+14K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+15K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+15K260524uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)…Shanghai United Imaging Healthcare Co., Ltd.20260—
+15K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—