# K234009: Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

- Pathway: 510(k) (Traditional)
- Applicant: Mighty Oak Medical
- Decided: Jul 12, 2024 after 206 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: 6 generations back to K924630 (1993). 8 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183105: Mimics Medical, Materialise NV (2019) Summary page 5.
- K183489: D2P, 3D Systems, Inc. (2019) Summary page 5.

## Most influential descendants
- K252103: Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (2025), 1 descendant of its own
- K260322: Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (2026), 0 descendants of its own
- K251532: Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (2025), 0 descendants of its own

## Indications for use
Acorn Segmentation is intended for use as a software interface and image segmentation system for the transfer of CT or CTA medical images to an output file. Acorn Segmentation is also intended for measuring and treatment planning. The Acorn 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. Acorn Segmentation and 3DP Models should be used in conjunction with expert clinical judgment.

Source page: https://510kreport.com/device/K234009
Methodology: https://510kreport.com/methodology