# K211966: Segment 3DPrint

- Pathway: 510(k) (Traditional)
- Applicant: Medviso AB
- Decided: May 6, 2022 after 316 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.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183105: Mimics Medical, Materialise NV (2019) Summary page 4.

## Indications for use
Segment 3DPrint is a software for review and segmentation of images from a medical scanner as well as of medical 3D models. Segment 3DPrint is intended to generate 3D models for diagnostic purposes in both paediatric and adult populations in the field of orthopaedic, maxillofacial, and cardiovascular applications. The models can be used for visualisation, measuring, and treatment planning. Output from Segment 3DPrint can be used to fabricate physical replicas, by use of additive manufacturing methods. Segment 3DPrint is intended to be used by medically trained professionals in conjunction with expert clinical judgement.

Source page: https://510kreport.com/device/K211966
Methodology: https://510kreport.com/methodology