# K160315: I4 (Integrated Intelligent Imaging Informatics) system

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Feb 19, 2016 after 14 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 K913770 (1991). 14 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111804: Intellispace Pacs 4.X, Philips Healthcare Informatics, Inc. (2011) Summary page 5.

## Most influential descendants
- K173588: Illumeo System (2018), 2 descendants of its own
- K250181: AV Viewer (2025), 1 descendant of its own
- K261465: Indira Cloud Viewer (2026), 0 descendants of its own

## Indications for use
I4 (Integrated Intelligent Imaging Informatics) is an image management system intended to be used by trained professionals, including but not limited to radiologists. I4 (Integrated Intelligent Imaging Informatics) system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, manipulation and quantification of images, communication and storage. This device is not to be used for mammography.

Source page: https://510kreport.com/device/K160315
Methodology: https://510kreport.com/methodology