510(k) Report

Devices descending from K221511

4 later devices reach Axial3D Cloud Segmentation Service through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231607Axial3D Cloud Segmentation ServiceAxial Medical Printing Limited20240—
+1K222745Axial3D InsightAxial Medical Printing Limited20232—
+2K232841Axial3D InsightAxial Medical Printing Limited20231—
+3K250369Axial3D InsightAxial Medical Printing Limited20250—