Cleared Traditional

Critical Care Suite with Endotracheal Tube Positing AI algorithm

K211161 · Ge Medical Systems, LLC · Radiology
Oct 2021
Decision
193d
Days
Class 2
Risk

About This 510(k) Submission

K211161 is an FDA 510(k) clearance for the Critical Care Suite with Endotracheal Tube Positing AI algorithm, a Automated Radiological Image Processing Software (Class II — Special Controls, product code QIH), submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on October 29, 2021, 193 days after receiving the submission on April 19, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K211161 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2021
Decision Date October 29, 2021
Days to Decision 193 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.