Devices · Fujifilm Corporation

Synapse Lung Nodule AI

Fujifilm Corporation is listed for Synapse Lung Nodule AI (K254075). The FDA list gives May 27, 2026 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code OEB as “Lung Computed Tomography System, Computer-Aided Detection”: To assist radiologists in the review of multi-slice computed tomography (msct) exams of the chest and highlight potential nodules that the radiologist should review. A computer aided diagnosis, lung computed tomography system is a class 3 device under product code NRR. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254075

Official FDA database record

Date of final decision

May 27, 2026

Company on the FDA list

Fujifilm Corporation

Lead panel

Radiology

Primary product code

OEB

openFDA device name for the code

Lung Computed Tomography System, Computer-Aided Detection

Device class

2

Regulation number

892.2050

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary