007ffd87-3aa5-430a-b846-10fb64c86472UpdatePublished32024-08-202022-07-25In Commercial DistributionG003DM01PrimaryHIBCC3D Anatomic Model1043964519Ricoh Usa, Inc.13D printed patient specific replicas of patient anatomyfalsefalsefalsefalsefalsetruefalsetruetruefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse62215Custom-made organ/bone anatomy modelA model of an organ (e.g., heart, kidney, lung) or bone of a specific patient intended to be used to assist anatomical visualization and surgical treatment planning. It is created using additive (three-dimensional [3-D] printing) processes based on patient medical images. It is typically made of a synthetic polymer, marked with a unique identifier.falseActiveLLZSystem, Image Processing, Radiologicalfalsefalse