# K242647: MySegmenter (v2.0.0)

- Pathway: 510(k) (Traditional)
- Applicant: Mysegmenter Technologies, Inc.
- Decided: Apr 16, 2025 after 225 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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: 5 generations back to K924630 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 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 9.

## Indications for use
MySegmenter (v2.0.0) is a medical images segmentation tool that converts CT and MRI scans into 3D anatomical models. The models are intended for surgical planning or educational purposes but are not to be used in the operating room. The software must be used under the supervision of qualified medical professionals. The 3D models and replicas are to be utilized solely for pre-operational planning in orthopedic and craniomaxillofacial cases, and for educational purposes; they must not be used in the operating room. The MR images have not been tested for craniomaxillofacial applications

Source page: https://510kreport.com/device/K242647
Methodology: https://510kreport.com/methodology