510(k) Report

Devices descending from K934915

1,096 later devices reach Acuson Model 2001 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+15K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+15K260844ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20260—
+15K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+15K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+15K260589ES-SeriesE-Scopics20260—
+15K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+15K253221Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)Eieling Technology (Shenzhen) Limited20260—
+15K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5Canon Medical Systems Corporation20252—
+15K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+15K242496Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)Eieling Technology (Shenzhen) Limited20240—
+15K240906TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+15K240516RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+15K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+15K232459VelacurSonic Incytes20232—
+15K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+15K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20231—
+15K223564X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20230—
+15K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202311—
+15K222596S90 Exp Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20233—
+15K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+15K220851VenueGE Medical Systems20223—
+15K220848Venue FitGE Medical Systems202241
+15K220800Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202232
+15K220295Arietta 50Fujifilm Healthcare Corporation20220—
+15K213642Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 ExpertGE Healthcare20221—
+15K210438Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+15K211488Logiq E10GE Healthcare202111—
+15K211524LOGIQ E10s, LOGIQ FortisGE Healthcare20218—
+15K201988T-LiteSonoscanner20201—
+15K190646QT Scanner 2000 Model AQt Ultrasound, LLC20192—
+15K182648X5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20190—
+15K182596Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20182—
+15K181783Logiq P9; Logiq P7GE Healthcare2018171
+15K180535Voluson P6 and Voluson P8GE Healthcare2018121
+15K152567Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound SystemGE Healthcare2015154—
+16K254027Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…Sonoscape Medical Corp.20260—
+16K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+16K254028Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV…Sonoscape Medical Corp.20260—
+16K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+16K253597Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20260—
+16K252498Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11…Sonoscape Medical Corp.20250—
+16K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20250—
+16K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20251—
+16K250024TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+16K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+16K242005Versana Premier; Versana Premier Lotus; LOGIQ FGE Medical Systems Ultrasound and Primary Care Diagnostics202402
+16K233977VelacurSonic Incytes20241—
+16K240053Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+16K240206Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+16K234106Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+16K240111VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+16K233692Voluson Signature 20, Voluson Signature 18GE Medical Systems Ultrasound and Primary Care Diagnostics20240—
+16K232285U-Lite PROSonoscanner Sarl20240—
+16K232381LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+16K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202301
+16K232988Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20230—
+16K231966Logiq E10GE Medical Systems Ultrasound and Primary Care Diagnostics20235—
+16K231989LOGIQ E10s, LOGIQ FortisGe Medical Systems Ultrasound and Primary Care Diagnostic,20235—
+16K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic…Samsung Medison Co., Ltd.20238—
+16K220933QT Scanner 2000 Model AQt Imaging, Inc.20221—
+16K213689Voluson P6, Voluson P8GE Healthcare20220—
+16K203114Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+16K201828Voluson SWIFT, Voluson SWIFT+GE Medical Systems Ultrasound and Primary Care Diagnostics202010—
+17K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…Philips Ultrasound, LLC20260—
+17K253720uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace…Wuhan United Imaging Healthcare Co.,Ltd20260—
+17K253716uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super…Wuhan United Imaging Healthcare Co.,Ltd20260—
+17K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.20260—
+17K253370LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+17K253366LOGIQ FortisGE Medical Systems Ultrasound and Primary Care Diagnostics20262—
+17K251985Logiq E10GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+17K251963LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+17K251322Venue; Venue Go; Venue Fit; Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+17K251728Velacur One (LI-1100)Sonic Incytes Medical Corp20250—
+17K240676ULTIMUS Series Ultrasound Diagnostic SystemVinno Technology (Suzhou) Co.,Ltd20240—
+17K241029SpineUs™ SystemVerdure Imaging20240—
+17K240631V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20247—
+17K230365Sonio DetectSonio20237—
+17K230346Voluson SWIFT; Voluson SWIFT+Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC20231—
+17K214039Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics202203
+18K261668Venue GoGE Medical Systems Ultrasound and Primary care Diagnostics, LLC20260—
+18K261835LOGIQ FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+18K260673LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ…GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+18K250543Voluson™ Performance 16; Voluson™ Performance 18GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+18K242594DeepechoDeepecho20250—
+18K243702V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic…Samsung Medison Co., Ltd.20254—
+18K242511V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic…Samsung Medison Co., Ltd.20240—
+18K241971HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20241—
+18K233955Clarius OB AIClarius Mobile Health Corp.20240—
+18K240406Sonio DetectSonio20244—
+19K252433Sonio Detect (v3)Sonio20260—
+19K252018HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s…Samsung Medison Co., Ltd.20260—
+19K250959BioticsAIBioticsai, Inc.20250—
+19K250999V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic…Samsung Medison Co., Ltd.20252—
+19K241380Fetoly-HeartDiagnoly20241—
+20K261412V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System…Samsung Medison Co., Ltd.20261—
+20K251368FetolyDiagnoly20250—