# K220649: Elucis

- Pathway: 510(k) (Traditional)
- Applicant: Realize Medical, Inc.
- Decided: Jan 17, 2023 after 316 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 5.

## Indications for use
Elucis is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. It is also intended for measuring and treatment planning. Elucis should be used in conjunction with expert clinical judgement.

Source page: https://510kreport.com/device/K220649
Methodology: https://510kreport.com/methodology