# K240554: InferRead Lung CT.AI

- Pathway: 510(k) (Traditional)
- Applicant: Infervision Medical Technology Co., Ltd.
- Decided: May 16, 2025 after 443 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: 12 generations back to K913770 (1991). 165 ancestors in all.
No later device cites it as a predicate yet.
0 of 166 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192880: InferRead Lung CT.AI, Beijing Infervision Technology Co., Ltd. (2020) Summary page 5.
- K162484: Lung Nodule Assessment and Comparison Option (LNA), Philips Medical Systems Nederland B.V. (2017) Summary page 6.

## 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 ≥ 4mm during the review of CT examinations of the chest on an asymptomatic population ≥ 55 years old. 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/K240554
Methodology: https://510kreport.com/methodology