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FDA-cleared K253192

DeepXray Spina

Alpha Intelligence Manifolds, Inc.

Authorized purpose: 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 negative result does not rule out low BMD.

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

DeepXray

Alpha Intelligence Manifolds, Inc.

Authorized purpose: 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 sclerosis, joint-space narrowing, and osteophytes under OARSI criteria, and assessing radiographic knee osteoarthritis under Kellgren-Lawrence grading of standing fixed-flexion knee radiographs. It must not replace full patient evaluation or be relied on alone for diagnosis.

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