# K251763: IRISeg

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Dec 16, 2025 after 190 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: 12 generations back to K924630 (1993). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242461: IRISeg, Intuitive Surgical, Inc. (2024) Summary page 5.

## Indications for use
IRISeg is intended for use as a software application that receives DICOM compliant MR or contrast-enhanced CT images, provides manual and machine learning-enabled tools for image analysis and segmentation, and creates an output file that can be used to render a 3D model for preoperative surgical planning and intraoperative display. The use of IRISeg may include the generation of preliminary segmentations using machine learning algorithms. IRISeg is intended for use by qualified professionals. The output file is meant for visual, non-diagnostic use and shall be reviewed by clinicians who are responsible for all final patient management decisions. The machine learning enabled kidney CT auto-segmentation tool is intended for use for adult patients with contrast-enhanced, axial kidney CT images with slice thickness 3mm or less.

Source page: https://510kreport.com/device/K251763
Methodology: https://510kreport.com/methodology