510(k) K254075 ยท OEB Lung Computed Tomography System, Computer-Aided Detection
Synapse Lung Nodule AI
| Applicant | Fujifilm Corporation, Minato-Ku, Tokyo, JP |
| Decision | Substantially Equivalent, May 27, 2026 |
| Received | Dec 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254075
No recall in the FDA data names this 510(k).
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