Cleared Traditional

Synapse 3D Base Tools (V7.0)

K243762 · Fujifilm Corporation · Radiology
May 2025
Decision
166d
Days
Class 2
Risk

About This 510(k) Submission

K243762 is an FDA 510(k) clearance for the Synapse 3D Base Tools (V7.0), a Automated Radiological Image Processing Software (Class II — Special Controls, product code QIH), submitted by Fujifilm Corporation (Minato-Ku, JP). The FDA issued a Cleared decision on May 21, 2025, 166 days after receiving the submission on December 6, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K243762 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 2024
Decision Date May 21, 2025
Days to Decision 166 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code QIH — Automated Radiological Image Processing Software
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050
Definition To Provide Automated Radiological Image Processing And Analysis Tools. Software Implementing Artificial Intelligence Including Nonadaptive Machine Learning Algorithms Trained With Clinical And/or Artificial Data. In These Devices, The Algorithm Training Data Typically Impacts Device Performance. Adaptive Ai Algorithms Are Not Within Scope Of This Product Code.