# K171199: AVIEW

- Pathway: 510(k) (Traditional)
- Applicant: Coreline Soft Co., Ltd.
- Decided: Oct 31, 2018 after 555 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: 8 generations back to K954355 (1995). 12 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151919: Vitrea CT Lung Density Analysis Software, Vital Images, Inc. (2015) Summary page 5.

## Most influential descendants
- K200714: AVIEW (2020), 5 descendants of its own
- K214036: AVIEW (2022), 4 descendants of its own
- K233211: Aview Cac (2024), 2 descendants of its own
- K250288: TeraRecon Cardiovascular.Calcification.CT (2025), 0 descendants of its own
- K243689: AVIEW (2025), 0 descendants of its own

## Indications for use
AVIEW provides CT values for pulmonary tissue from CT thoracic datasets. This software can be used to support the physician quantitatively in the diagnosis, followup evaluation and documentation of CT lung tissue images by providing image segmentation of sub-structures in the left and right lung (e.g., the five lobes and airway), volumetric and structural analysis, density evaluations and reporting tools. AVIEW is also used to store, transfer, inquire and display CT data sets. AVIEW is not meant for primary image Interpretation in mammography.

Source page: https://510kreport.com/device/K171199
Methodology: https://510kreport.com/methodology