ChestView US
K241620Gleamer SAS · cleared 2025-02-27 · product code MYN · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.4)
“ChestView US is a radiological Computer-Assisted Detection (CADe) software device that analyzes frontal and lateral chest radiographs of patients presenting with symptoms (e.g. dyspnea, cough, pain) or suspected for findings related to regions of interest (ROIs) in the lungs, airways, mediastinum/hila and pleural space.”
AlgorithmSupervised Deep learning
source quote (p.9)
“Supervised Deep learning”
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)
Standalone
n=3,884 cases
endpoints: Area Under the Curve (AUC); sensitivity; specificity
Reader study (MRMC)
n=240 cases
endpoints: Area Under the Curve (AUC); specificity; sensitivity
Reported performance (20 observations)
aurocas written: “AUC Nodule”0.93CI [0.921; 0.938]
source quote (p.11)
“0.93 [0.921; 0.938]”
aurocas written: “AUC Mediastinum/Hila Abnormality”0.922CI [0.91; 0.934]
source quote (p.11)
“0.922 [0.91; 0.934]”
aurocas written: “AUC Consolidation”0.952CI [0.947; 0.957]
source quote (p.11)
“0.952 [0.947; 0.957]”
aurocas written: “AUC Pleural Space Abnormality”0.973CI [0.97; 0.975]
source quote (p.11)
“0.973 [0.97; 0.975]”
sensitivityas written: “Sensitivity Nodule (High-sensitivity operating point)”0.829CI [0.801; 0.86]
source quote (p.11)
“0.829 [0.801; 0.86]”
specificityas written: “Specificity Nodule (High-sensitivity operating point)”0.956CI [0.948; 0.963]
source quote (p.11)
“0.956 [0.948; 0.963]”
sensitivityas written: “Sensitivity Mediastinum/Hila Abnormality (High-sensitivity operating point)”0.793CI [0.739; 0.832]
source quote (p.11)
“0.793 [0.739; 0.832]”
specificityas written: “Specificity Mediastinum/Hila Abnormality (High-sensitivity operating point)”0.975CI [0.971; 0.98]
source quote (p.11)
“0.975 [0.971; 0.98]”
sensitivityas written: “Sensitivity Consolidation (High-sensitivity operating point)”0.853CI [0.822; 0.879]
source quote (p.11)
“0.853 [0.822; 0.879]”
specificityas written: “Specificity Consolidation (High-sensitivity operating point)”0.946CI [0.938; 0.952]
source quote (p.11)
“0.946 [0.938; 0.952]”
sensitivityas written: “Sensitivity Pleural Space Abnormality (High-sensitivity operating point)”0.892CI [0.87; 0.911]
source quote (p.11)
“0.892 [0.87; 0.911]”
specificityas written: “Specificity Pleural Space Abnormality (High-sensitivity operating point)”0.965CI [0.958; 0.971]
source quote (p.11)
“0.965 [0.958; 0.971]”
sensitivityas written: “Sensitivity Nodule (High-specificity operating point)”0.482CI [0.455; 0.518]
source quote (p.11)
“0.482 [0.455; 0.518]”
specificityas written: “Specificity Nodule (High-specificity operating point)”0.994CI [0.99; 0.996]
source quote (p.11)
“0.994 [0.99; 0.996]”
sensitivityas written: “Sensitivity Mediastinum/Hila Abnormality (High-specificity operating point)”0.535CI [0.475; 0.592]
source quote (p.11)
“0.535 [0.475; 0.592]”
specificityas written: “Specificity Mediastinum/Hila Abnormality (High-specificity operating point)”0.992CI [0.99; 0.994]
source quote (p.11)
“0.992 [0.99; 0.994]”
sensitivityas written: “Sensitivity Consolidation (High-specificity operating point)”0.61CI [0.583; 0.643]
source quote (p.11)
“0.61 [0.583; 0.643]”
specificityas written: “Specificity Consolidation (High-specificity operating point)”0.985CI [0.981; 0.989]
source quote (p.11)
“0.985 [0.981; 0.989]”
sensitivityas written: “Sensitivity Pleural Space Abnormality (High-specificity operating point)”0.87CI [0.85; 0.896]
source quote (p.11)
“0.87 [0.85; 0.896]”
specificityas written: “Specificity Pleural Space Abnormality (High-specificity operating point)”0.975CI [0.97; 0.981]
source quote (p.11)
“0.975 [0.97; 0.981]”
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
-100%
vs code's own 3-yr baseline
0
drift signals on this device
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).