Cleared Traditional

K251072 - Segmentron Viewer
(FDA 510(k) Clearance)

K251072 · DGNCT, LLC · Radiology
Sep 2025
Decision
155d
Days
Class 2
Risk

K251072 is an FDA 510(k) clearance for the Segmentron Viewer. This device is classified as a Automated Radiological Image Processing Software (Class II — Special Controls, product code QIH).

Submitted by DGNCT, LLC (Miami, US). The FDA issued a Cleared decision on September 9, 2025, 155 days after receiving the submission on April 7, 2025.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050. 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..

Submission Details

510(k) Number K251072 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 2025
Decision Date September 09, 2025
Days to Decision 155 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.