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FDA-cleared K231668

Spine CAMP™ (1.1)

Medical Metrics, Inc.

Authorized purpose: Analyze spine X-rays to produce static and/or motion metrics from sagittal lumbar and/or cervical radiographs, visualize intervertebral motion through image-registration stabilization, and support assessment of spinal stability, alignment, degeneration, fusion, motion preservation, and implant performance in skeletally mature patients aged 18 years and older.

Modality
X-ray/Radiography
Anatomy
Spine, including sagittal lumbar and cervical spine; femoral-head landmarks for spinopelvic measurements
Decision
2023-07-07
FDA-cleared K221632

Spine CAMP™

Medical Metrics, Inc.

Authorized purpose: Automated analysis of sagittal lumbar and cervical spine radiographs to produce static and motion metrics supporting qualified practitioners' decision-making in skeletally mature patients age 18 and above.

Modality
X-ray/Radiography
Anatomy
Spine
Decision
2022-10-18