Cleared Traditional

K223491 - Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K223491 is an FDA 510(k) clearance for the Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care S.... Classified as Radiological Computer Assisted Detection/diagnosis Software For Fracture (product code QBS), Class II - Special Controls.

Submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on May 25, 2023 after a review of 185 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2090 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

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Submission Details

510(k) Number K223491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 107d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QBS Radiological Computer Assisted Detection/diagnosis Software For Fracture
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.