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FDA-cleared K251078

AutoDensity

Eos Imaging

AutoDensity estimates L1-L4 spine bone-mineral density from EOSedge dual-energy AP radiographs for opportunistic orthopedic pre-surgical assessment; it is not a replacement for DXA confirmation.

Modality
X-ray/Radiography
Anatomy
Spine
Decision
2025-11-14
FDA-cleared K251747

VEA Align; spineEOS

EOS imaging

Authorized purpose: VEA Align is cloud-based software for orthopedic applications in adult and pediatric populations using two-dimensional X-ray images from EOS imaging systems to display interactive landmarks and assess patient-specific global alignment, with angle and length measurements for spinal deformities, degenerative diseases, and lower-limb alignment disorders or deformities. It is suitable for patients aged 7 years and older. spineEOS assists healthcare professionals with preoperative planning of spine surgery using EOS images, associated three-dimensional datasets, measurements, and patient-specific surgical-planning tools.

Modality
X-ray/Radiography
Anatomy
Spine and lower-limb alignment; frontal and lateral EOS images and associated 3D datasets
Decision
2025-08-15
FDA-cleared K240582

VEA Align; spineEOS

EOS imaging

Authorized purpose: VEA Align uses 2D X-ray images acquired in EOS imaging systems to display interactive landmarks and support global-alignment assessment, angle and length measurements, and analysis of spinal deformities, degenerative diseases, and lower-limb alignment disorders in pediatric and adult patients aged 7 years and older. spineEOS assists healthcare professionals with preoperative spine-surgery planning using EOS images, 3D datasets, measurements, and patient-specific surgical-strategy tools.

Modality
X-ray/Radiography
Anatomy
Spine and lower limbs; global alignment and deformity
Decision
2024-06-25
FDA-cleared K231917

VEA Align

EOS imaging

Authorized purpose: VEA Align is cloud-based orthopedic software that uses 2D frontal and lateral X-ray images acquired in EOS imaging systems to display interactive landmarks and support patient-specific global-alignment assessment, angle and length measurements, and analysis of spinal deformities, degenerative disease, lower-limb alignment disorders, and deformities in adults and children age 7 years and older.

Modality
X-ray/Radiography
Anatomy
Spine and lower-limb alignment anatomy
Decision
2024-01-05