510(k) Report

Devices descending from K011252

813 later devices reach Eub-6000 Diagnostic Ultrasound Scanner SP-711 Sonoprobe System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+14K240406Sonio DetectSonio20244—
+14K232988Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20230—
+14K220933QT Scanner 2000 Model AQt Imaging, Inc.20221—
+15K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…Philips Ultrasound, LLC20260—
+15K261132Healium Intelliscan LX192LCHealium Intelliscan Corporation20260—
+15K252433Sonio Detect (v3)Sonio20260—
+15K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.20260—
+15K252018HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s…Samsung Medison Co., Ltd.20260—
+15K250959BioticsAIBioticsai, Inc.20250—
+15K250999V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic…Samsung Medison Co., Ltd.20252—
+15K241380Fetoly-HeartDiagnoly20241—
+16K261412V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System…Samsung Medison Co., Ltd.20261—
+16K251368FetolyDiagnoly20250—