510(k) Report

Devices descending from K180535

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

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