FDA-cleared K253192

DeepXray Spina

Alpha Intelligence Manifolds, Inc.

Opportunistic review of frontal lumbar-spine or KUB radiographs in adults aged 50 years and older to flag possible low bone mineral density at L1-L4 for clinician follow-up; a...

Modality
X-ray/Radiography
Anatomy
Spine/Bone Health
Decision
2026-06-10
FDA-cleared K223621

DeepXray

Alpha Intelligence Manifolds, Inc.

DeepXray is a fully automated CR or DX radiographic image-processing device intended to aid trained medical professionals in measuring minimum joint-space width, assessing...

Modality
X-ray/Radiography
Anatomy
Knee; radiographic osteoarthritis features
Decision
2023-09-08