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510(k) K254075

Synapse Lung Nodule AI by Fujifilm Corporation — Product Code OEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2026
Date Received
December 18, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lung Computed Tomography System, Computer-Aided Detection
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

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.

Other clearances by Fujifilm Corporation

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  • K254189 — Synapse 3D Base Tools (V7.2) (April 30, 2026)
  • K253862 — APERTO Lucent MRI System (April 6, 2026)
  • K251861 — FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM (March 9, 2026)
  • K250550 — FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit (February 17, 2026)
  • K253568 — Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; (February 6, 2026)
  • K250863 — FUJIFILM Ultrasonic Endoscope EB-710US (December 12, 2025)
  • K251386 — ECHELON Synergy (September 17, 2025)
  • K244017 — FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 (June 13, 2025)
  • K243512 — FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM End (June 10, 2025)

Other clearances for product code OEB

  • K251203 — AVIEW Lung Nodule CAD (December 3, 2025)
  • K240554 — InferRead Lung CT.AI (May 16, 2025)
  • K242919 — V5med Lung AI (March 27, 2025)
  • K231157 — syngo.CT Lung CAD (Version VD30) (July 19, 2023)
  • K221592 — AVIEW Lung Nodule CAD (February 24, 2023)
  • K221612 — ClearRead CT (December 5, 2022)
  • K203258 — syngo.CT Lung CAD (March 31, 2021)
  • K201501 — Veolity (February 23, 2021)
  • K192880 — InferRead Lung CT.AI (July 2, 2020)
  • K193216 — syngo.CT Lung CAD (March 9, 2020)