Gleamer radiology AI products

Turn this list into an evaluation

Each entry is an FDA submission, not a distinct commercial offer. Inspect the exact record before comparing evidence, asking for a quote or planning an integration.

Which exact product, version and licensed modules are in the current offer?
Do related FDA submissions document the same scope, or different functions and versions?
Which costs, support obligations and local acceptance tests remain unresolved?

Prepare with a buyer guide:

Radiology AI pricing and total cost of ownership

Clinical guide links appear when this list contains a current reviewed example. They do not classify or endorse the other entries. All buyer guides · Compare exact records · Documented families

FDA-cleared K222176

BoneView

Gleamer

Authorized purpose: 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, thoracic spine, and lumbosacral spine are limited to adults older than 21 years. Clinical users retain diagnostic and patient-management responsibility.

Modality: X-ray/Radiography
Anatomy: Spine
Decision: 2023-03-02

MSK and bone

FDA-cleared K212365

BoneView

Gleamer

Concurrent-reading software that highlights suspected fractures on labeled adult radiographs for physician review.

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