# K062650: EP Navigator Software

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems
- Decided: Sep 21, 2006 after 14 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: 6 generations back to K890348 (1989). 36 ancestors in all.
49 later devices descend from it; 2 cite it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042293: Brilliance CT, Private Practice CV Configuration, CT Scanner, Philips Medical Systems (Cleveland), Inc. (2004) Summary page 1.
- K041955: Gemini Pet/CT Imaging System, Philips Medical Systems (Cleveland), Inc. (2004) Summary page 1.
- K042334: Allura 3D-CA, Release 1, Philips Medical Systems North America Co. (2004) Summary page 1.
- K040254: Integris 3D-RA, Release 4.2, Philips Medical Systems North America Co. (2004) Summary page 1.
- K031836: Philips Fresco Release 1, Philips Medical Systems North America Co. (2003) Summary page 1.
- K060749: Xperct, Philips Medical Systems North America Co. (2006) Summary page 1.

## Most influential descendants
- 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
- K172607: Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System (2017), 28 descendants of its own
- K181485: EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System (2018), 27 descendants of its own

## Indications for use
EP-Navigator is intended to enable users to segment previously acquired 3D CT datasets and overlay and register these 3D segmented data sets with live fluoro X-ray images of the same anatomy in order to support catheter/device navigation during specified procedures.

Source page: https://510kreport.com/device/K062650
Methodology: https://510kreport.com/methodology