Cleared Traditional

DS Core Diagnosis

K250755 · Dentsply Sirona, Inc. · Radiology
Aug 2025
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K250755 is an FDA 510(k) clearance for the DS Core Diagnosis, a Automated Radiological Image Processing Software (Class II — Special Controls, product code QIH), submitted by Dentsply Sirona, Inc. (York, US). The FDA issued a Cleared decision on August 12, 2025, 153 days after receiving the submission on March 12, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K250755 FDA.gov
FDA Decision Cleared SESE
Date Received March 12, 2025
Decision Date August 12, 2025
Days to Decision 153 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.