# K260116: CustoMED Viewer

- Pathway: 510(k) (Traditional)
- Applicant: CustoMED, Ltd.
- Decided: Jun 3, 2026 after 140 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: 7 generations back to K924630 (1993). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170419: SurgiCase Viewer, Materialise NV (2017) Summary page 5.

## Indications for use
CustoMED Viewer is intended to be used as a software interface to assist in visualization and communication of treatment options.

Source page: https://510kreport.com/device/K260116
Methodology: https://510kreport.com/methodology