# K061995: Xcelera

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America Co.
- Decided: Sep 6, 2006 after 54 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: 4 generations back to K954479 (1996). 9 ancestors in all.
128 later devices descend from it; 7 cite it directly.
0 of 138 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022788: Philips Harmony Release 1, Philips Medical Systems North America Co. (2002) Summary page 2.
- K042203: Leonardo Syngo Cardiology Workstation, Siemens Medical Solutions USA, Inc. (2004) Summary page 2.

## Most influential descendants
- K083348: Image-Arena Applications (2008), 89 descendants of its own
- K090461: Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0 (2009), 86 descendants of its own
- K120135: 2D Cardiac Performance Analysis MR 1.0 (2012), 82 descendants of its own
- K110746: 4D LV-Analysis 3.0 (2011), 80 descendants of its own
- K110667: Image-Arena and Image-Arena Applications (2011), 80 descendants of its own

## Indications for use
Philips Xcelera software is an integrated multimodality image and information system, designed to perform the necessary functions required for import /export/ storage / archiving/ review / analysis/ quantification (for example: area, circumference, volume, velocity, length, percent, time, ejection fraction, pressure gradient, LV volumes) / reporting and database management of digital cardiovascular images, waveforms and data related to cardiology. Xcelera offers support for third party plug-ins in order to enable the use of commercially available tools and for analysis, quantification and reporting Xcelera offers support to launch specified 3 rd party programs from the user interface (Desktop Integration). It allows multiple users fast access to, and exchange of specific and/or multiple cardiology exams. Philips Xcelera software runs on standard information technology hardware and software. The Xcelera proprietary software product utilizes the standard Microsoft Windows Operating System and user interface. Communication and data exchange are done using standard TCP/IP, DICOM and HL7 protocols. Philips Xcelera will also be made available for use on specified Cardiovascular Monitoring Systems, which use suitable hardware components. Thre 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/K061995
Methodology: https://510kreport.com/methodology