ChestView US

K241620

Gleamer 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. The device uses machine learning techniques to identify and produces boxes around the ROIs.”
AlgorithmSupervised Deep learning
source quote (p.10)
“Supervised Deep learning”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Bench

n=3,884 images

endpoints: Area Under the Curve (AUC) of the Receiver Operating Characteristic (ROC) curve; high sensitivity; high specificity

Reader study (MRMC)

n=240 cases

endpoints: determine whether the accuracy of readers (radiologists and emergency medicine physicians) aided by ChestView US (“Aided”) was superior to the accuracy of readers when unaided by ChestView US (“Unaided") as determined by the case-level Area Under the Curve (AUC) of the Receiver Operating Characteristic (ROC) curve; The specificity and the sensitivity for each of the four categories of ROI detected by ChestView US was also reported at the case-level and ROI level

Reported performance (20 observations)

aurocas written: “AUC - Nodule”0.93CI [0.921; 0.938]
source quote (p.11)
“NODULE 0.93 [0.921; 0.938]”
aurocas written: “AUC - Mediastinum/Hila Abnormality”0.922CI [0.91; 0.934]
source quote (p.11)
“MEDIASTINUM/HILA ABNORMALITY 0.922 [0.91; 0.934]”
aurocas written: “AUC - Consolidation”0.952CI [0.947; 0.957]
source quote (p.11)
“CONSOLIDATION 0.952 [0.947; 0.957]”
aurocas written: “AUC - Pleural Space Abnormality”0.973CI [0.97; 0.975]
source quote (p.11)
“PLEURAL SPACE ABNORMALITY 0.973 [0.97; 0.975]”
sensitivityas written: “Sensitivity (High-sensitivity operating point) - Nodule”0.956CI [0.948; 0.963]
source quote (p.11)
“NODULE 0.956 [0.948; 0.963]”
specificityas written: “Specificity (High-sensitivity operating point) - Nodule”0.829CI [0.801; 0.86]
source quote (p.11)
“NODULE 0.829 [0.801; 0.86]”
sensitivityas written: “Sensitivity (High-sensitivity operating point) - Mediastinum/Hila Abnormality”0.975CI [0.971; 0.98]
source quote (p.11)
“MEDIASTINUM/HILA ABNORMALITY 0.975 [0.971; 0.98]”
specificityas written: “Specificity (High-sensitivity operating point) - Mediastinum/Hila Abnormality”0.793CI [0.739; 0.832]
source quote (p.11)
“MEDIASTINUM/HILA ABNORMALITY 0.793 [0.739; 0.832]”
sensitivityas written: “Sensitivity (High-sensitivity operating point) - Consolidation”0.946CI [0.938; 0.952]
source quote (p.11)
“CONSOLIDATION 0.946 [0.938; 0.952]”
specificityas written: “Specificity (High-sensitivity operating point) - Consolidation”0.853CI [0.822; 0.879]
source quote (p.11)
“CONSOLIDATION 0.853 [0.822; 0.879]”
sensitivityas written: “Sensitivity (High-sensitivity operating point) - Pleural Space Abnormality”0.965CI [0.958; 0.971]
source quote (p.11)
“PLEURAL SPACE ABNORMALITY 0.965 [0.958; 0.971]”
specificityas written: “Specificity (High-sensitivity operating point) - Pleural Space Abnormality”0.892CI [0.87; 0.911]
source quote (p.11)
“PLEURAL SPACE ABNORMALITY 0.892 [0.87; 0.911]”
sensitivityas written: “Sensitivity (High-specificity operating point) - Nodule”0.482CI [0.455; 0.518]
source quote (p.11)
“NODULE 0.482 [0.455; 0.518]”
specificityas written: “Specificity (High-specificity operating point) - Nodule”0.994CI [0.99; 0.996]
source quote (p.11)
“NODULE 0.994 [0.99; 0.996]”
sensitivityas written: “Sensitivity (High-specificity operating point) - Mediastinum/Hila Abnormality”0.535CI [0.475; 0.592]
source quote (p.11)
“MEDIASTINUM/HILA ABNORMALITY 0.535 [0.475; 0.592]”
specificityas written: “Specificity (High-specificity operating point) - Mediastinum/Hila Abnormality”0.992CI [0.99; 0.994]
source quote (p.11)
“MEDIASTINUM/HILA ABNORMALITY 0.992 [0.99; 0.994]”
sensitivityas written: “Sensitivity (High-specificity operating point) - Consolidation”0.61CI [0.583; 0.643]
source quote (p.11)
“CONSOLIDATION 0.61 [0.583; 0.643]”
specificityas written: “Specificity (High-specificity operating point) - Consolidation”0.985CI [0.981; 0.989]
source quote (p.11)
“CONSOLIDATION 0.985 [0.981; 0.989]”
sensitivityas written: “Sensitivity (High-specificity operating point) - Pleural Space Abnormality”0.87CI [0.85; 0.896]
source quote (p.11)
“PLEURAL SPACE ABNORMALITY 0.87 [0.85; 0.896]”
specificityas written: “Specificity (High-specificity operating point) - Pleural Space Abnormality”0.975CI [0.97; 0.981]
source quote (p.11)
“PLEURAL SPACE ABNORMALITY 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); 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/K241620