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, deep learning algorithm
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 (2)

Bench

sample size not stated

endpoints: The average time to acquire, annotate, process and transfer an image from the x-ray system to PACS was measured and found to take 42 seconds on average.

Retrospective clinical

n=804 images

endpoints: The algorithm ROC AUC meets the performance requirement of FDA product code QFM (AUC>95%): AUC=96% (95% CI [94.9% - 97.2%]) (PTX present: N=376; PTX absent: N=428).; 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%]).

Reported performance (7 observations)

sensitivity84.3CI 95% CI [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 95% CI [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”0.96CI 95% CI [94.9% - 97.2%]
source quote (p.9)
“The algorithm ROC AUC meets the performance requirement of FDA product code QFM (AUC>95%): AUC=96% (95% CI [94.9% - 97.2%]) (PTX present: N=376; PTX absent: N=428).”
aurocas written: “AUC on large pneumothorax”0.9888CI 95% CI [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 95% CI [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 95% CI [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 95% CI [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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
2
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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K183182