Critical Care Suite

K183182

GE Medical Systems, LLC. · cleared 2019-08-12 · product code QFM · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“Critical Care Suite is a software module that employs AI-based image analysis algorithms to identify pre-specified critical findings (pneumothorax) in frontal chest X-ray images and flag the images in the PACS/workstation to enable prioritized review by the radiologist.”

AlgorithmAI-based image analysis algorithms, specifically a deep learning algorithm trained on annotated medical images

source quote (p.5)

“Critical Care Suite is a software module that employs AI-based image analysis algorithms to identify pre-specified critical findings (pneumothorax) in frontal chest X-ray images and flag the images in the PACS/workstation to enable prioritized review by the radiologist. Specifically, the proposed and predicate software utilize a deep learning algorithm trained on annotated medical images.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=804 images

endpoints: ROC AUC; Specificity; Sensitivity; Sensitivity on large pneumothorax; Sensitivity on small pneumothorax

Reported performance (7 observations)

sensitivity84.3CI [80.6%, 88.0%]

source quote (p.9)

“Critical Care Suite performs at high specificity 93.5% (95% CI [91.1% - 95.8%]) and high sensitivity 84.3% (95% CI [80.6% – 88.0%]).”

specificity93.5CI [91.1%, 95.8%]

source quote (p.9)

“Critical Care Suite performs at high specificity 93.5% (95% CI [91.1% - 95.8%]) and high sensitivity 84.3% (95% CI [80.6% – 88.0%]).”

aurocas written: “auc”0.9607CI [0.9491, 0.9724]

source quote (p.7)

“AUC: 0.9607 (95% CI [0.9491, 0.9724])”

aurocas written: “AUC on large pneumothorax”0.9888CI [0.9810, 0.9965]

source quote (p.7)

“AUC on large pneumothorax 0.9888 (95% CI [0.9810, 0.9965])”

sensitivityas written: “Sensitivity on large pneumothorax”96.3CI [93.3%, 99.2%]

source quote (p.7)

“Sensitivity on large pneumothorax 96.3% (95% CI [93.3%, 99.2%]”

aurocas written: “AUC on small pneumothorax”0.9389CI [0.9209, 0.9570]

source quote (p.7)

“AUC on small pneumothorax 0.9389 (95% CI [0.9209, 0.9570])”

sensitivityas written: “Sensitivity on small pneumothorax”75CI [69.2%, 80.8%]

source quote (p.7)

“Sensitivity on small pneumothorax 75% (95% CI [69.2%, 80.8%])”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

re_clearance
The FDA AI/ML device list shows a newer 510(k) K223491 (decision 2023-05-25) from GE Medical Systems, LLC for a matching device line ("Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K223491
re_clearance
The FDA AI/ML device list shows a newer 510(k) K211161 (decision 2021-10-29) from GE Medical Systems, LLC for a matching device line ("Critical Care Suite with Endotracheal Tube Positing AI algorithm") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K211161

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).