# K254075: Synapse Lung Nodule AI

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Corporation
- Decided: May 27, 2026 after 160 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.
No later device cites it as a predicate yet.
0 of 146 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 5.

## Indications for use
The Synapse Lung Nodule AI is a computer-assisted detection software device intended to be used as concurrent reader to aid the radiologist in the detection of pulmonary nodules during the review of CT examinations of the chest on the lung cancer screening population according to the lung cancer screening protocols. The Synapse Lung Nodule AI requires that both lungs be in the field of view. The Synapse Lung Nodule AI provides adjunctive information such as bounding boxes, segmented contours, and measurement values, and is not intended to be used without the original CT series. The Synapse Lung Nodule AI is also not intended to be used for the differentiation of the detected regions between benign and malignant.

Source page: https://510kreport.com/device/K254075
Methodology: https://510kreport.com/methodology