# K183489: D2P

- Pathway: 510(k) (Traditional)
- Applicant: 3D Systems, Inc.
- Decided: Aug 29, 2019 after 255 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K924630 (1993). 6 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161841: D2P, 3D Systems, Inc. (2017) Summary page 4.

## Most influential descendants
- K234009: Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (2024), 3 descendants of its own
- K252103: Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (2025), 1 descendant of its own
- K201835: Pre-Sure (2021), 1 descendant of its own
- K260322: Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (2026), 0 descendants of its own
- K251532: Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (2025), 0 descendants of its own

## Indications for use
The D2P software is intended for use as a software interface and image segmentation system for the transfer of DICOM imaging information from a medical scanner to an output file. It is also intended as pre-operative software for surgical planning. For this purpose, the output file may be used to produce a physical replica. The physical replica is intended for adjunctive use along with other diagnostic tools and expert clinical judgement for diagnosis, patient management, and/or treatment selection of cardiovascular, craniofacial, gastrointestinal, genitourinary, neurological, and/or musculoskeletal applications.

Source page: https://510kreport.com/device/K183489
Methodology: https://510kreport.com/methodology