Cleared Traditional

IRISeg

K251763 · Intuitive Surgical, Inc. · Radiology
Dec 2025
Decision
190d
Days
Class 2
Risk

About This 510(k) Submission

K251763 is an FDA 510(k) clearance for the IRISeg, a Automated Radiological Image Processing Software (Class II — Special Controls, product code QIH), submitted by Intuitive Surgical, Inc. (Suunyvale, US). The FDA issued a Cleared decision on December 16, 2025, 190 days after receiving the submission on June 9, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K251763 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 2025
Decision Date December 16, 2025
Days to Decision 190 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.