# K111804: Intellispace Pacs 4.X

- Pathway: 510(k) (Traditional)
- Applicant: Philips Healthcare Informatics, Inc.
- Decided: Jul 28, 2011 after 31 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K913770 (1991). 13 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063267: Isite Pacs, V 4. X, Stentor Inc., A Philips Medical Systems Co. (2006) Summary page 1.

## Most influential descendants
- K160315: I4 (Integrated Intelligent Imaging Informatics) system (2016), 3 descendants of its own
- 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
- K182926: IntelliSpace Radiology (2018), 0 descendants of its own

## Recalls of this device
- Apr 19, 2019 · Class II · Z-2338-2020: Images may potentially become corrupt while using the system.
- Jul 24, 2014 · Class II · Z-2252-2014: A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information is changed in the DICOM header and the study is exported before the image is updated in the PACS, the u

## Indications for use
IntelliSpace PACS 4.x is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The 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, communication and storage. Lossy compressed mammographic images and digitized screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Source page: https://510kreport.com/device/K111804
Methodology: https://510kreport.com/methodology