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

🇺🇸Ge Medical Systems, LLC · Radiological Computer Assisted Detection/Diagnosis Software For Fracture

What it does

Supports the imaging workflow around multi-modality studies — routing, scheduling, or image management — rather than interpreting the images.

Who it's for

Imaging departments and informatics teams managing study flow.

Reported performance

No sensitivity / specificity / AUC was disclosed in the available summary. Many summaries report no standalone metrics — we note that honestly rather than imply a number.

Performance numbers are manufacturer-reported and often single-site; treat them as a starting point, not an independent benchmark.

FDA

Pathway510(k)
Submission #K223491
Product codeQBS
Decision dateMay 25, 2023
PanelRadiology
FDA recordaccessdata

EU (CE)

Statusunknown
Risk class
Notified body
EMDN code
Basic UDI-DI
AI Act class

EU coverage is filling out through 2026; absence here doesn't mean a device isn't CE-marked.

Vendor

Foundedunknown

Cite this page

RadPigeon. "Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite (Ge Medical Systems, LLC)." AI Devices registry. https://radpigeon.news/ai/device/critical-care-suite-with-pneumothorax-detection-ai-algorithm-critical-care-suite

Last updated Jun 29, 2026. Information only — not clinical advice. Summaries are RadPigeon's own wording.