Synapse Lung Nodule AI— 510(k) K254075
Substantially EquivalentFujifilm Corporation
FDA 510(k) clearance K254075 for Synapse Lung Nodule AI, Substantially Equivalent on 2026-05-27. Applicant: Fujifilm Corporation. Device class: 2.
Summary
Fujifilm's Synapse Lung Nodule AI is filed under OEB, computer-aided detection for lung computed tomography systems.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Fujifilm filed from Minato-Ku, Tokyo, Japan. Review took 160 calendar days (December 18, 2025 to May 27, 2026).
Clearance details
- Applicant
- Fujifilm Corporation
- Product code
- Product code OEB
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minato-Ku, Tokyo, JP
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