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Critical Care Suite

πŸ‡ΊπŸ‡ΈGe Medical Systems, LLC Β· Lesion detection/diagnosis software

What it does

Marks areas of interest on multi-modality images to support the radiologist's read as a second pair of eyes; the radiologist makes the call.

Who it's for

Radiologists who want a detection aid on these studies and programs aiming to improve consistency.

Reported performance

No sensitivity / specificity / AUC was disclosed in the available summary. Many summaries report no standalone metrics β€” 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 #K183182
Product codeQFM
Decision dateAug 12, 2019
PanelRadiology
FDA recordaccessdata

EU (CE)

Statusunknown
Risk classβ€”
Notified bodyβ€”
EMDN codeβ€”
Basic UDI-DIβ€”
AI Act classβ€”

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

Vendor

Cite this page

RadPigeon. "Critical Care Suite (Ge Medical Systems, LLC)." AI Devices registry. https://radpigeon.news/ai/device/critical-care-suite

Last updated Jun 30, 2026. Information only β€” not clinical advice. Summaries are RadPigeon's own wording.