510(k) Report

Devices descending from K022567

1,069 later devices reach Sequoia Signature II Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+13K211524LOGIQ E10s, LOGIQ FortisGE Healthcare20218—
+13K201988T-LiteSonoscanner20201—
+13K190646QT Scanner 2000 Model AQt Ultrasound, LLC20192—
+13K182648X5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20190—
+13K182596Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20182—
+13K181783Logiq P9; Logiq P7GE Healthcare2018171
+13K180535Voluson P6 and Voluson P8GE Healthcare2018121
+13K152567Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound SystemGE Healthcare2015154—
+14K254027Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…Sonoscape Medical Corp.20260—
+14K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+14K254028Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV…Sonoscape Medical Corp.20260—
+14K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+14K253597Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20260—
+14K252498Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11…Sonoscape Medical Corp.20250—
+14K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20250—
+14K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20251—
+14K250024TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+14K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+14K242005Versana Premier; Versana Premier Lotus; LOGIQ FGE Medical Systems Ultrasound and Primary Care Diagnostics202402
+14K233977VelacurSonic Incytes20241—
+14K240053Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+14K240206Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+14K234106Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+14K240111VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+14K233692Voluson Signature 20, Voluson Signature 18GE Medical Systems Ultrasound and Primary Care Diagnostics20240—
+14K232285U-Lite PROSonoscanner Sarl20240—
+14K232381LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+14K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202301
+14K232988Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20230—
+14K231966Logiq E10GE Medical Systems Ultrasound and Primary Care Diagnostics20235—
+14K231989LOGIQ E10s, LOGIQ FortisGe Medical Systems Ultrasound and Primary Care Diagnostic,20235—
+14K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic…Samsung Medison Co., Ltd.20238—
+14K220933QT Scanner 2000 Model AQt Imaging, Inc.20221—
+14K213689Voluson P6, Voluson P8GE Healthcare20220—
+14K203114Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+14K201828Voluson SWIFT, Voluson SWIFT+GE Medical Systems Ultrasound and Primary Care Diagnostics202010—
+15K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…Philips Ultrasound, LLC20260—
+15K253720uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace…Wuhan United Imaging Healthcare Co.,Ltd20260—
+15K253716uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super…Wuhan United Imaging Healthcare Co.,Ltd20260—
+15K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.20260—
+15K253370LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+15K253366LOGIQ FortisGE Medical Systems Ultrasound and Primary Care Diagnostics20262—
+15K251985Logiq E10GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+15K251963LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+15K251322Venue; Venue Go; Venue Fit; Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+15K251728Velacur One (LI-1100)Sonic Incytes Medical Corp20250—
+15K240676ULTIMUS Series Ultrasound Diagnostic SystemVinno Technology (Suzhou) Co.,Ltd20240—
+15K241029SpineUs™ SystemVerdure Imaging20240—
+15K240631V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20247—
+15K230365Sonio DetectSonio20237—
+15K230346Voluson SWIFT; Voluson SWIFT+Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC20231—
+15K214039Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics202203
+16K261668Venue GoGE Medical Systems Ultrasound and Primary care Diagnostics, LLC20260—
+16K261835LOGIQ FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+16K260673LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ…GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+16K250543Voluson™ Performance 16; Voluson™ Performance 18GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+16K242594DeepechoDeepecho20250—
+16K243702V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic…Samsung Medison Co., Ltd.20254—
+16K242511V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic…Samsung Medison Co., Ltd.20240—
+16K241971HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20241—
+16K233955Clarius OB AIClarius Mobile Health Corp.20240—
+16K240406Sonio DetectSonio20244—
+17K252433Sonio Detect (v3)Sonio20260—
+17K252018HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s…Samsung Medison Co., Ltd.20260—
+17K250959BioticsAIBioticsai, Inc.20250—
+17K250999V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic…Samsung Medison Co., Ltd.20252—
+17K241380Fetoly-HeartDiagnoly20241—
+18K261412V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System…Samsung Medison Co., Ltd.20261—
+18K251368FetolyDiagnoly20250—