Cleared Traditional

K254075 - Synapse Lung Nodule AI (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K254075 · Fujifilm Corporation · Radiology device
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May 2026
Decision
160d
Days
Class 2
Risk

K254075 is an FDA 510(k) clearance for the Synapse Lung Nodule AI. Classified as Lung Computed Tomography System, Computer-aided Detection (product code OEB), Class II - Special Controls.

Submitted by Fujifilm Corporation (Minato-Ku, Tokyo, JP). The FDA issued a Cleared decision on May 27, 2026 after a review of 160 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fujifilm Corporation devices

Submission Details

510(k) Number K254075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2025
Decision Date May 27, 2026
Days to Decision 160 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 107d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OEB Lung Computed Tomography System, Computer-aided Detection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition 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 this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

FUJIFILM Healthcare Americas Corporation
Chaitrali Kulkarni

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OEB Lung Computed Tomography System, Computer-aided Detection

All 19
Devices cleared under the same product code (OEB) and FDA review panel - the closest regulatory comparables to K254075.
AVIEW Lung Nodule CAD
K251203 · Coreline Soft Co., Ltd. · Dec 2025
InferRead Lung CT.AI
K240554 · Infervision Medical Technology Co., Ltd. · May 2025
V5med Lung AI
K242919 · V5med, Inc. · Mar 2025
syngo.CT Lung CAD (Version VD30)
K231157 · Siemens Healthcare GmbH · Jul 2023
AVIEW Lung Nodule CAD
K221592 · Coreline Soft Co., Ltd. · Feb 2023
ClearRead CT
K221612 · Riverain Technologies, Inc. · Dec 2022