# K153022: Philips IntelliSpace Cardiovascular

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Nethrlands BV
- Decided: Nov 18, 2015 after 34 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K954479 (1996). 10 ancestors in all.
21 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061995: Xcelera, Philips Medical Systems North America Co. (2006) Summary page 4.

## Most influential descendants
- K153736: 3mensio Workstation (2016), 19 descendants of its own
- K202212: TruPlan (2021), 3 descendants of its own
- K222593: TruPlan Computed Tomography (CT) Imaging Software (2023), 2 descendants of its own
- K191585: iNtuition-Structural Heart Module (2019), 2 descendants of its own
- K190874: Materialise Mimics Enlight (2019), 2 descendants of its own

## Recalls of this device
- Aug 8, 2025 · Class II · Z-2543-2025: Software issue that results in the display of outdated information.
- Apr 7, 2025 · Class II · Z-1740-2025: An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.
- Apr 4, 2024 · Class II · Z-1252-2025: Study data is not able to be archived, copied, or exported with the cardiovascular software version.

## Indications for use
Philips IntelliSpace Cardiovascular software product is an integrated multimodality image and information system designed to perform the necessary functions required for import, export, storage, archival, review, analysis, quantification, reporting and database management of digital cardiovascular images, waveforms and data related to cardiology. Philips IntelliSpace Cardiovascular offers support for third party applications in order to enable the use of commercially available tools and specified applications for analysis, quantification and reporting. It allows multiple users fast access to, and exchange of specific and/or multiple cardiology exams. Philips IntelliSpace Cardiovascular software runs on standard information technology hardware and software, utilizing the standard information technology operating systems and user interface. Communication and data exchange are done using standard protocols. Philips IntelliSpace Cardiovascular will also be made available for use on specified Cardiovascular Monitoring Systems, which use suitable hardware components. The modular design allows configurability to tailor the image import, archive and communications solution to one's particular budgetary and performance needs. The number of modalities and reporting and/or viewing sites can be configured per system.

Source page: https://510kreport.com/device/K153022
Methodology: https://510kreport.com/methodology