510(k) Report

Devices descending from K991671

809 later devices reach Hdi 5000 Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+13K220933QT Scanner 2000 Model AQt Imaging, Inc.20221—
+14K252433Sonio Detect (v3)Sonio20260—
+14K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.20260—
+14K252018HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s…Samsung Medison Co., Ltd.20260—
+14K250959BioticsAIBioticsai, Inc.20250—
+14K250999V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic…Samsung Medison Co., Ltd.20252—
+14K241380Fetoly-HeartDiagnoly20241—
+15K261412V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System…Samsung Medison Co., Ltd.20261—
+15K251368FetolyDiagnoly20250—