# K994210: Inturis Suite

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems, Inc.
- Decided: Feb 4, 2000 after 52 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: 2 generations back to K954479 (1996). 3 ancestors in all.
142 later devices descend from it; 3 cite it directly.
0 of 146 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972229: Imageview Coronary Angiography Display and Review System, Heartware, Inc. (1997) Summary page 2.

## Most influential descendants
- K022788: Philips Harmony Release 1 (2002), 129 descendants of its own
- K061995: Xcelera (2006), 128 descendants of its own
- 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

## Indications for use
Philips Inturis Suite is intended to be used for the display and reading of cardiac angiographic images stored on a compact disk (CD) or an image server. Inturis Suite also allows the user to change the appearance of the images and export selected frames to other programs for printing and further manipulation.

Source page: https://510kreport.com/device/K994210
Methodology: https://510kreport.com/methodology