# K260322: Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

- Pathway: 510(k) (Traditional)
- Applicant: Mighty Oak Medical
- Decided: Jun 11, 2026 after 132 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K904519 (1991). 46 ancestors in all.
No later device cites it as a predicate yet.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K252103: Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX), Mighty Oak Medical (2025) Summary page 5.

## Indications for use
Acorn 3D Software is a modular image processing software intended for use as an interface for visualization of medical images, segmentation, anatomical measurements, treatment planning, treatment simulation, and production of an output file. The Acorn 3D Segmentation module is intended for use as a software interface and image segmentation system for the transfer of CT, sCT, or CTA medical images to an output file. Acorn 3D Segmentation is also intended for measuring and treatment planning. The Acorn 3D Segmentation output can also be used for the fabrication of physical replicas of the output file using additive manufacturing methods, Acorn 3DP Models. The physical replica can be used for diagnostic purposes in the field of musculoskeletal and craniomaxillofacial applications. The Acorn 3D Alignment and Measurement module contains registration capabilities and measurement functionality based on anatomical reference geometry. It is intended to allow the user to align anatomical structures between datasets, perform spinopelvic measurements on 3D models of anatomy, and plan surgical procedures in pediatric and adult patients. The Acorn 3D Trajectory Automation module may be used to plan pedicle screw placement in the thoracic and lumbar regions of the spine in pediatric and adult patients. The Acorn 3D Correction module may be used to plan and simulate aspects of surgical procedures in pediatric and adult patients. Acorn 3D Software and 3DP Models should be used in conjunction with expert clinical judQment.

Source page: https://510kreport.com/device/K260322
Methodology: https://510kreport.com/methodology