FDA-cleared K241620

ChestView US

Gleamer SAS

Concurrent reading aid for adult frontal and lateral chest radiographs, marking suspected nodules, pleural-space abnormalities, mediastinal/hilar abnormalities and consolidations.

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2025-02-27
FDA-cleared K241593

BoneMetrics (US)

Gleamer SAS

BoneMetrics is fully automated software that assists trained radiology professionals with Cobb-angle measurement on frontal spine radiographs in patients aged four years or older...

Modality
X-ray/Radiography
Anatomy
Spine
Decision
2025-02-05