# K182643: IRIS 1.0 System

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical
- Decided: Feb 22, 2019 after 151 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: 10 generations back to K924630 (1993). 12 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173274: Ceevra Reveal 2.0, Ceevra, Inc. (2018) Summary page 4.

## Most influential descendants
- K242461: IRISeg (2024), 1 descendant of its own
- K251763: IRISeg (2025), 0 descendants of its own

## Indications for use
The IRIS 1.0 System is intended as a medical imaging system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from CT imaging devices. It is also intended as software for preoperative surgical planning, and as software for the intraoperative display of the aforementioned multidimensional digital images. The IRIS 1.0 System is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.

Source page: https://510kreport.com/device/K182643
Methodology: https://510kreport.com/methodology