# K192040: AVIEW Modeler

- Pathway: 510(k) (Traditional)
- Applicant: Coreline Soft Co., Ltd.
- Decided: Dec 20, 2019 after 142 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)
- K161841: D2P, 3D Systems, Inc. (2017) Summary page 4.

## Indications for use
The AVIEW Modeler is intended for use as an image review and segmentation system that operates on DICOM imaging information obtained from a medical scanner. It is also used as a pre-operative software for surgical planning. 3D printed models generated from the output file are for visualization and educational purposes only and not for diagnostic use.

Source page: https://510kreport.com/device/K192040
Methodology: https://510kreport.com/methodology