Cleared Traditional

Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite

K223491 · Ge Medical Systems, LLC · Radiology
May 2023
Decision
185d
Days
Class 2
Risk

About This 510(k) Submission

K223491 is an FDA 510(k) clearance for the Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite, a Radiological Computer Assisted Detection/diagnosis Software For Fracture (Class II — Special Controls, product code QBS), submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on May 25, 2023, 185 days after receiving the submission on November 21, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2090.

Submission Details

510(k) Number K223491 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2022
Decision Date May 25, 2023
Days to Decision 185 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code QBS — Radiological Computer Assisted Detection/diagnosis Software For Fracture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2090
Definition A Radiological Computer Assisted Detection And Diagnostic Software For Suspected Fracture Is An Image Processing Device Intended To Aid In The Detection, Localization, And/or Characterization Of Fracture On Acquired Medical Images (e.g. Radiography, Mr, Ct). The Device Detects, Identifies And/or Characterizes Fracture Based On Features Or Information Extracted From Images, And May Provide Information About The Presence, Location, And/or Characteristics Of The Fracture To The User. Primary Diagnostic And Patient Management Decisions Are Made By The Clinical User.