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FDA-cleared K231955

aprevo® Digital Segmentation

Carlsmed, Inc.

Authorized purpose: aprevo Digital Segmentation is software for trained, medically knowledgeable design personnel to perform digital image segmentation of the spine, primarily lumbar anatomy; it inputs DICOM images and outputs a three-dimensional spine model.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Spine, primarily lumbar anatomy
Decision
2023-11-03