510(k) Report

Devices descending from K161841

8 later devices reach D2P through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192040AVIEW ModelerCoreline Soft Co., Ltd.20190—
+1K183489D2P3D Systems, Inc.20196—
+2K234009Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20243—
+2K201835Pre-SureLazarus 3D, Inc.20211—
+3K252103Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20251—
+3K251532Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20250—
+3K230044Pre-SureLazarus 3D20230—
+4K260322Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20260—