Mighty Oak Medical radiology AI products

FDA-cleared K260322

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

Mighty Oak Medical

Acorn 3D Software and Acorn 3DP Model process CT, synthetic CT, and CT angiography for segmentation, visualization, measurement, treatment planning, and three-dimensional...

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

MSK and bone Quantification and segmentation

FDA-cleared K252103

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

Mighty Oak Medical

Acorn 3D Software provides modular image processing, visualization, segmentation, measurement, treatment planning, and three-dimensional-printing support; Acorn Trajectory...

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

MSK and bone Quantification and segmentation

FDA-cleared K251532

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

Mighty Oak Medical

Acorn 3D Software with Acorn 3DP Model provides modular image processing, visualization, segmentation, measurements, treatment planning, and three-dimensional models, including...

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

MSK and bone Quantification and segmentation

FDA-cleared K234009

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

Mighty Oak Medical

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...

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

Quantification and segmentation