# K040254: Integris 3D-RA, Release 4.2

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America Co.
- Decided: Feb 19, 2004 after 15 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 K974367 (1998). 2 ancestors in all.
84 later devices descend from it; 6 cite it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983877: Philips Integris 3D RA Option, Philips Medical Systems North America, Inc. (1998) Summary page 1.

## Most influential descendants
- K042334: Allura 3D-CA, Release 1 (2004), 51 descendants of its own
- K062650: EP Navigator Software (2006), 49 descendants of its own
- K101311: EP Navigator R3 (2010), 41 descendants of its own
- K111245: Heartnavigator Release 1 (2011), 39 descendants of its own
- K121781: Echonavigator Release 1 (2012), 32 descendants of its own

## Indications for use
The Integris 3D-RA release 4.2 is intended to assist the physicians when analyzing 2-Dimensional, DSA X-ray images by creating 3-Dimensional views from sets of 2-Dimensional images created during rotational angiographic runs.

Source page: https://510kreport.com/device/K040254
Methodology: https://510kreport.com/methodology