510(k) Report

Devices descending from K935009

1,062 later devices reach Pegasus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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
+16K231966Logiq E10GE Medical Systems Ultrasound and Primary Care Diagnostics20235—
+16K231989LOGIQ E10s, LOGIQ FortisGe Medical Systems Ultrasound and Primary Care Diagnostic,20235—
+16K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20232—
+16K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic…Samsung Medison Co., Ltd.20238—
+16K220619Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202222
+16K213689Voluson P6, Voluson P8GE Healthcare20220—
+16K202658Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics20215—
+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—
+16K182213QT Ultrasound Breast Scanner - 1Qt Ultrasound, LLC20183—
+16K172276Xario 200 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation20173—
+16K162187Xario 100 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201601
+17K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+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—
+17K253597Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20260—
+17K253370LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+17K253366LOGIQ FortisGE Medical Systems Ultrasound and Primary Care Diagnostics20262—
+17K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+17K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20250—
+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—
+17K223832Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics202312
+17K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And20222—
+17K214039Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics202203
+17K190646QT Scanner 2000 Model AQt Ultrasound, LLC20192—
+17K182596Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20182—
+18K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+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—
+18K251169Vivid PioneerGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+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—
+18K232988Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20230—
+18K220933QT Scanner 2000 Model AQt Imaging, Inc.20221—
+19K252433Sonio Detect (v3)Sonio20260—
+19K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.20260—
+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—