# K200713: EchoNavigator

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Apr 9, 2020 after 22 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: 10 generations back to K890348 (1989). 65 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121781: Echonavigator Release 1, Philips Medical Systems Nederland B.V. (2012) Summary page 4.

## Most influential descendants
- K221270: EchoNavigator R4.0 (2022), 1 descendant of its own
- K253614: EchoNavigator R5.0 (2026), 0 descendants of its own

## Indications for use
EchoNavigator supports the interventionalist and surgeon in treatments where both live X-ray and live Echo guidance are used. The targeted patient population consists of patients with cardiovascular diseases requiring such a treatment.

Source page: https://510kreport.com/device/K200713
Methodology: https://510kreport.com/methodology