Radiology · 510(k) · 2026
Synapse Lung Nodule AI
Fujifilm Corporation. Cleared by FDA on 27 May 2026 under submission K254075, product code OEB (lung computed tomography system, computer-aided detection). What FDA's record says, in FDA's words.
Device record · K254075
- Device. Synapse Lung Nodule AIDEVICE
- Company. Fujifilm Corporation (JP)COMPANY
- Decision. 27 May 2026, 510(k), substantially equivalent (traditional review); received 18 December 2025DECISION
- Panel. RadiologyPANEL
- Product code. OEB, Lung Computed Tomography System, Computer-Aided DetectionCODE
- Regulation. 21 CFR 892.2050, Class IIREG
- Source. FDA database entry · decision document (17 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
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.
The product code's definition, from FDA's classification record. 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.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedCT
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsdetection or identification of findings
- Mentionsmeasurement or quantification
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code OEB. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code OEB, in Radiology, from Fujifilm Corporation, or cleared in 2026. The whole record is at FDA AI-enabled medical devices.
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