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FDA-cleared K241620

ChestView US

Gleamer SAS

Authorized purpose: 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

Authorized purpose: 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 with suspected or present spinal deformity or scoliosis; it is not a replacement for complete evaluation or sole diagnosis.

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