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FDA-cleared K260322

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

Mighty Oak Medical

Authorized purpose: Acorn 3D Software and Acorn 3DP Model process CT, synthetic CT, and CT angiography for segmentation, visualization, measurement, treatment planning, and three-dimensional printing, including adult and pediatric spine trajectory planning.

Modality
CT/CTA
Anatomy
Spine; craniomaxillofacial; musculoskeletal anatomy; and patient-specific printed models
Decision
2026-06-11
FDA-cleared K252103

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

Mighty Oak Medical

Authorized purpose: Acorn 3D Software provides modular image processing, visualization, segmentation, measurement, treatment planning, and three-dimensional-printing support; Acorn Trajectory Automation plans pedicle-screw trajectories in adult and pediatric thoracic and lumbar spine cases.

Modality
CT/CTA
Anatomy
Thoracic and lumbar spine, musculoskeletal, craniomaxillofacial, and vascular anatomy
Decision
2025-12-02
FDA-cleared K251532

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

Mighty Oak Medical

Authorized purpose: Acorn 3D Software with Acorn 3DP Model provides modular image processing, visualization, segmentation, measurements, treatment planning, and three-dimensional models, including pedicle-screw trajectory planning for adult and pediatric thoracic and lumbar spine cases.

Modality
CT/CTA
Anatomy
Thoracic and lumbar spine, musculoskeletal, craniomaxillofacial, and vascular anatomy
Decision
2025-11-03
FDA-cleared K234009

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

Mighty Oak Medical

Authorized purpose: Acorn Segmentation is intended as an image-segmentation interface for transferring CT or CTA images to an output file, measuring, and treatment planning. The output can be used to fabricate Acorn 3DP Models by additive manufacturing for diagnostic musculoskeletal and craniomaxillofacial applications.

Modality
CT/CTA
Anatomy
Musculoskeletal and craniomaxillofacial anatomy
Decision
2024-07-12