510(k) Report

Devices descending from K163394

6 later devices reach Hybrid3D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171719Hybrid3DHermes Medical Solutions AB20175—
+2K181468Hybrid3DHermes Medical Solutions AB20184—
+3K202882AffinityHermes Medical Solutions AB20201—
+3K202392SIR-Spheres Microspheres Activity Calculator (SMAC)Sirtex Medical US Holdings, Inc.20200—
+3K193152AffinityHermes Medical Solutions AB20200—
+4K253835AffinityHermes Medical Solutions AB20260—