# K192880: InferRead Lung CT.AI

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Infervision Technology Co., Ltd.
- Decided: Jul 2, 2020 after 267 days
- Product code: OEB (Lung Computed Tomography System, Computer-Aided Detection)
- 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: 11 generations back to K913770 (1991). 145 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 147 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161201: ClearRead CT, Riverain Technologies, LLC (2016) Summary page 4.

## Most influential descendants
- K240554: InferRead Lung CT.AI (2025), 0 descendants of its own

## Indications for use
InferRead Lung CT.AI is comprised of computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during the review of CT examinations of the chest on an asymptomatic population. InferRead Lung CT.AI requires that both lungs be in the field of view. InferRead Lung CT.AI provides adjunctive information and is not intended to be used without the original CT series.

Source page: https://510kreport.com/device/K192880
Methodology: https://510kreport.com/methodology