# K220205: 3D Anatomic Models

- Pathway: 510(k) (Traditional)
- Applicant: Ricoh USA, Inc.
- Decided: Jun 3, 2022 after 129 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.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173619: Mimics inPrint, Materialise NV (2018) Summary page 4.

## Most influential descendants
- K230119: 3D Anatomic Model (2023), 0 descendants of its own

## Indications for use
Ricoh 3D Anatomic Models are intended as physical replicas of patient anatomy to be used for diagnostic purposes in the fields of craniomaxillofacial and orthopedic applications. The Anatomic Models are based on DICOM imaging information from a medical scanner and output files from FDA cleared software intended for the creation and output of digital files suitable for the fabrication of physical replicas. The models should be used in conjunction with other diagnostic tools and expert clinical judgement.

Source page: https://510kreport.com/device/K220205
Methodology: https://510kreport.com/methodology