510(k) Report

Devices descending from K022303

1,155 later devices reach Philips M2424 Diagnostic Ultrasound System &Philips 21315 Diagnostic… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K251322Venue; Venue Go; Venue Fit; Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+12K251728Velacur One (LI-1100)Sonic Incytes Medical Corp20250—
+12K250024TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+12K242499Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))Shenzhen Sontu Medical Imaging Equipment Co., Ltd.20250—
+12K240676ULTIMUS Series Ultrasound Diagnostic SystemVinno Technology (Suzhou) Co.,Ltd20240—
+12K241029SpineUs™ SystemVerdure Imaging20240—
+12K240631V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20247—
+12K240053Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+12K240206Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+12K234106Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+12K233532MULTIX Impact ESiemens Medical Solutions20230—
+12K223832Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics202312
+12K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And20222—
+12K220295Arietta 50Fujifilm Healthcare Corporation20220—
+12K213642Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 ExpertGE Healthcare20221—
+12K201988T-LiteSonoscanner20201—
+12K181783Logiq P9; Logiq P7GE Healthcare2018171
+12K182213QT Ultrasound Breast Scanner - 1Qt Ultrasound, LLC20183—
+12K180535Voluson P6 and Voluson P8GE Healthcare2018121
+12K172276Xario 200 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation20173—
+12K162187Xario 100 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201601
+12K152567Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound SystemGE Healthcare2015154—
+13K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd.20260—
+13K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+13K261668Venue GoGE Medical Systems Ultrasound and Primary care Diagnostics, LLC20260—
+13K261835LOGIQ FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+13K260673LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ…GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+13K251169Vivid PioneerGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+13K243702V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic…Samsung Medison Co., Ltd.20254—
+13K242511V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic…Samsung Medison Co., Ltd.20240—
+13K241971HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20241—
+13K233692Voluson Signature 20, Voluson Signature 18GE Medical Systems Ultrasound and Primary Care Diagnostics20240—
+13K232285U-Lite PROSonoscanner Sarl20240—
+13K213689Voluson P6, Voluson P8GE Healthcare20220—
+13K203114Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+13K201828Voluson SWIFT, Voluson SWIFT+GE Medical Systems Ultrasound and Primary Care Diagnostics202010—
+13K190646QT Scanner 2000 Model AQt Ultrasound, LLC20192—
+13K182596Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20182—
+14K252018HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s…Samsung Medison Co., Ltd.20260—
+14K250999V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic…Samsung Medison Co., Ltd.20252—
+14K232988Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20230—
+14K230365Sonio DetectSonio20237—
+14K230346Voluson SWIFT; Voluson SWIFT+Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC20231—
+14K220933QT Scanner 2000 Model AQt Imaging, Inc.20221—
+14K214039Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics202203
+15K261412V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System…Samsung Medison Co., Ltd.20261—
+15K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.20260—
+15K250543Voluson™ Performance 16; Voluson™ Performance 18GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+15K242594DeepechoDeepecho20250—
+15K233955Clarius OB AIClarius Mobile Health Corp.20240—
+15K240406Sonio DetectSonio20244—
+16K252433Sonio Detect (v3)Sonio20260—
+16K250959BioticsAIBioticsai, Inc.20250—
+16K241380Fetoly-HeartDiagnoly20241—
+17K251368FetolyDiagnoly20250—