510(k) Report

Devices descending from K191216

5 later devices reach Voxel Dosimetry™ v1.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243919Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB20252—
+1K220630TorchTM SoftwareVoximetry, Incorporated20221—
+2K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC20260—
+2K253835AffinityHermes Medical Solutions AB20260—
+2K241765PLANET Onco Dose (3.2)Dosisoft SA20250—