510(k) Report

Devices descending from K930768

221 later devices reach Orion Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K993365GE Logiq 700 with Harmonic Imaging ModificationGe Medical Systems, Inc.19990—
+1K993364GE Logiq 700 with Coded Excitation ModificationGe Medical Systems, Inc.19990—
+1K990226GE LOGIQ700 Diagnostic Ultrasound System with B-FlowGe Medical Systems, Inc.19992—
+1K964617GE Logiq 700 Diagnostic Ultrasound SystemGE Medical Systems1997217—
+1K960527Logiq 1000 Diagnostic Ultrsound SystemGE Medical Systems19973—
+1K964886GE Logiq 700 Diagnostic Ultrasound SystemGE Medical Systems19972—
+2K990248Dicom Image Manager, Model 3-D Visualization OptionDicomit Imaging Systems Corp.1999213—
+2K990256CRX World ShuntPhoenix Biomedical Corp.19990—
+3K992886Powerview Ultrasound Workstation, Uidm-400AToshiba America Medical Systems, In.C1999212—
+4K022400Ssa-700A, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C20022101
+4K013633Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C2001211—
+5K032281Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2003209—
+6K063130Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0Toshibamedical Systems Corporation20062051
+6K041499Ssa-770A, Aplio Version 5.5Toshibamedical Systems Corporation200423
+7K072826Aplio Artida Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2007182—
+7K072000Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0Toshiba America Medical Systems, In.C2007203—
+7K053043Encompass Software PackageToshiba America Medical Systems, In.C20050—
+7K050380Xario Diagnostic Ultrasound System, Model Ssa-660AToshiba America Medical Systems, In.C200502
+8K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+8K081065Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A, Version 2.2Toshiba America Medical Systems, In.C2008118—
+8K080160Aplio Artida, Model SSH-880CV Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2008181—
+8K072918Model Ssa-680A Xario XG Diagnostic Ultrasound System, Version 1.00Toshibamedical Systems Corporation200703
+9K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+9K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+9K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+9K090158Aplio Artida V2.0 SSH-880CVToshiba America Medical Systems, In.C2009985
+9K0826844D Viewer Radiology, Model Uswp-100AToshiba America Medical Systems, In.C20080—
+9K082596Ultraextend Usws-900AToshiba America Medical Systems, In.C200882—
+9K082119Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 3.0Toshiba America Medical Systems, In.C2008116—
+10K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+10K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+10K131822Ultraextend Usws-900A V2.1 and V3.1Toshiba America Medical Systems, In.C20130—
+10K121577Aplio Artida Diagnostic Ultrasound SystemToshiba Medical Systems Corporation, Japan201229—
+10K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+10K1107464D LV-Analysis 3.0Tomtec Imaging Systems GmbH201180—
+10K091295Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0Toshiba America Medical Systems, In.C2009222
+11K2301796440 MyLabX90Esaote, S.p.A.202341
+11K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+11K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+11K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+11K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+11K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+11K140729Aplio Artida, V3.2Toshiba America Medical Systems, In.C201428—
+11K132544Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH201378—
+11K120282CardnavPaieon, Inc.20120—
+11K121076Ultraextend FX, Ultrasound Workstation PackageToshiba America Medical Systems, In.C20122—
+11K121422Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan201285—
+11K100067Model Viamo Ssa-640A, Version 2.0 Ultrasound SystemToshiba America Medical Systems, In.C20101—
+11K093171Viamo Ssa-640A Version 1.2Toshiba America Medical Systems, In.C200911—
+11K092948Aplio MX Ssa-780A, Version 1.0Toshiba America Medical Systems, In.C200901
+11K092179Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 4.0R001Toshiba America Medical Systems, In.C200991
+12K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+12K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+12K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+12K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramCanon Medical Systems Corporation20250—
+12K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+12K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+12K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+12K200232LVivo Software ApplicationDia Imaging Analysis, Ltd.202019—
+12K192372ASCEND Image ViewerAscend Hit20200—
+12K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20193—
+12K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+12K161960bk2300Bk Medical Aps20165—
+12K150122Tomtec-Arena TTA2Tomtec Imaging Systems GmbH2015561
+12K142197Ultrasound System Sonimage HS1, Linear Probe L18-4, Convex Probe C5-2Konica Minolta, Inc.201452
+12K132677Ultrasound Scanner Flex Focus 1202B-K Medical Aps20140—
+12K132685Ultrasound Scanner Pro Focus 2202B-K Medical Aps20140—
+12K123992Aplio 500/400/300 V3.0Toshibamedical Systems Corporation201382—
+12K122009Aida VI.8 Diagnostic Ultrasound GM-72P00A, L13-5V1 TransducerPanasonic Healthcare Co., Ltd.20120—
+12K111142Echosoft (TM)Echometrix, LLC20120—
+12K122491Viamo Ssa-640A V4.0Toshibamedical Systems Corporation20120—
+12K113612Aida V1.5 Diagnostic Ultrasound System GM-72P00APanasonic Healthcare Co., Ltd.20121—
+12K103148Aida Diagnostic Ultrasound SystemPanasonic Healthcare Co., Ltd.20112—
+12K103629Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C20116—
+13K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+13K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+13K223322Argus Cognitive ReVISION SoftwareArgus Cognitive, Inc.20231—
+13K222406Clarius AIClarius Mobile Health Corp.20233—
+13K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+13K210053LVivo Software ApplicationDia Imaging Analysis, Ltd.202111—
+13K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+13K202364Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20201—
+13K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+13K202546LVivo SeamlessDia Imaging Analysis, Ltd.20202—
+13K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+13K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+13K191171EchoGo CoreUltromics, Ltd.20193—
+13K180737Ultrasound Scanner System bk2300Bk Medical Aps20182—
+13K173569Ultrasound System 1300Bk Medical Aps20181—
+13K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+13K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+13K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+13K151060Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201541
+13K133761Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation201472—
+13K131507Xario 200 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20139—
+14K251417ReVISION 2Argus Cognitive, Inc.20260—
+14K260192DIANAROPCA ApS20260—
+14K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.20260—
+14K252235PVAD IQ SoftwareUltrasight, Ltd.20250—
+14K250670EchoConfidence (USA)Mycardium AI Limited20250—