510(k) Report

Devices descending from K201828

10 later devices reach Voluson SWIFT, Voluson SWIFT+ through their predicates, nearest generation first.

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