# K180129: Imbio Segmentation Editing Tool software

- Pathway: 510(k) (Traditional)
- Applicant: Imbio, LLC
- Decided: Mar 16, 2018 after 58 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: 9 generations back to K954874 (1996). 53 ancestors in all.
No later device cites it as a predicate yet.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103576: Mim 5.2 (Brachy), Mim Software, Inc. (2011) Summary page 4.

## Indications for use
The Imbio Segmentation Editing Tool Software is used by trained medical professionals as a tool to modify the contours of segmentation masks produced by Imbio algorithms or to manually create segmentation mask contours. The Segmentation Editing Tool can provide further support to the users of Imbio’s algorithms.

Source page: https://510kreport.com/device/K180129
Methodology: https://510kreport.com/methodology