510(k) Report

Devices descending from K171719

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

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