Radiology AI Directory

Vendor

Gleamer

2 FDA-cleared listings in this directory.

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FDA-cleared K222176

BoneView

Gleamer

BoneView 1.1-US analyzes eligible 2D radiographs as a concurrent fracture-reading aid. Limb examinations apply to patients aged 2 years and older; pelvis, hip, femur, ribs,...

Modality
X-ray/Radiography
Anatomy
Spine
Decision
2023-03-02
MSK and bone
FDA-cleared K212365

BoneView

Gleamer

BoneView is a concurrent reading aid that analyzes radiographs and highlights areas suspicious for fractures in adults during physician interpretation.

Modality
X-ray/Radiography
Anatomy
Ankle, foot, knee, tibia/fibula, femur, wrist, hand, elbow, forearm, humerus, shoulder, clavicle, pelvis, hip, ribs, thoracic spine, and lumbosacral spine
Decision
2022-03-01
MSK and bone