510(k) Report

Devices descending from K193417

8 later devices reach FractureDetect (FX) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220164RayvolveAzmed Sas20223—
+1K212365BoneViewGleamer20223—
+2K240845RayvolveAzmed Sas20242—
+2K223491Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1…Ge Medical Systems, LLC20230—
+2K222176BoneViewGleamer20231—
+3K260378RayvolveAZmed20261—
+3K242171TechCare TraumaMilvue20250—
+4K261378Rayvolve AZchestAZmed20260—