510(k) Report

Devices descending from K141675

14 later devices reach Voluson P6, Voluson P8 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160162Voluson P6, Voluson P8GE Healthcare201613—
+2K180535Voluson P6 and Voluson P8GE Healthcare2018121
+3K213689Voluson P6, Voluson P8GE Healthcare20220—
+3K201828Voluson SWIFT, Voluson SWIFT+GE Medical Systems Ultrasound and Primary Care Diagnostics202010—
+4K230365Sonio DetectSonio20237—
+4K230346Voluson SWIFT; Voluson SWIFT+Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC20231—
+5K250543Voluson™ Performance 16; Voluson™ Performance 18GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+5K242594DeepechoDeepecho20250—
+5K233955Clarius OB AIClarius Mobile Health Corp.20240—
+5K240406Sonio DetectSonio20244—
+6K252433Sonio Detect (v3)Sonio20260—
+6K250959BioticsAIBioticsai, Inc.20250—
+6K241380Fetoly-HeartDiagnoly20241—
+7K251368FetolyDiagnoly20250—