Synapse Lung Nodule AI— 510(k) K254075

Substantially Equivalent

Fujifilm Corporation

FDA 510(k) clearance K254075 for Synapse Lung Nodule AI, Substantially Equivalent on 2026-05-27. Applicant: Fujifilm Corporation. Device class: 2.

Clearance details

Applicant: Fujifilm Corporation
Product code: Code OEB
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-12-18
Decision date: 2026-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minato-Ku, Tokyo, JP

Download summary PDF View on FDA.gov ↗

Recent devices under product code OEB

K251203 — AVIEW Lung Nodule CAD2025-12-03
K240554 — InferRead Lung CT.AI2025-05-16
K242919 — V5med Lung AI2025-03-27
K231157 — syngo.CT Lung CAD (Version VD30)2023-07-19
K221592 — AVIEW Lung Nodule CAD2023-02-24

More clearances from Fujifilm Corporation

K253836 — FCT iStream Phase 22026-09-04
K261170 — BA-004CC2026-08-12
K260567 — EW10-EC02 Endoscopy Support Program2026-08-07
K261880 — FUJIFILM Processor EP-8000; Balloon Controller PB-30; Endoscopy Support Program EW10-VM012026-07-02
K253137 — FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T2026-06-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.