510(k) Report

Devices descending from K030982

227 later devices reach Syngo Colonography Software Package through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+11K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+11K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+11K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+11K241211CoLumboSmart Soft Healthcare20242—
+11K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+11K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic…Samsung Medison Co., Ltd.20238—
+11K223564X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20230—
+11K220497CoLumboSmart Soft Healthcare AD20226—
+11K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+12K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+12K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+12K250367CoLumboXSmart Soft Healthcare AD20250—
+12K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+12K240793MSKaiMskai20240—
+12K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+12K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+12K240631V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20247—
+12K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+13K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd.20260—
+13K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+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—
+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—
+15K261412V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System…Samsung Medison Co., Ltd.20261—