# K152160: Navik 3D

- Pathway: 510(k) (Traditional)
- Applicant: Apn Health, LLC
- Decided: Feb 23, 2016 after 204 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K001437 (2000). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120550: Carto (R) EP Navigation System, Version 3.0 (with Standard Location Pad), Biosense Webster, Inc. (2012) Summary page 4.

## Recalls of this device
- Nov 7, 2023 · Class III · Z-0556-2024: IFU update

## Indications for use
Navik 3D is intended for catheter-based atrial and ventricular mapping using compatible catheters, and acquired data from compatible fluoroscopy systems and patient recording and monitoring systems. Navik 3D is intended to provide 3D location of these catheters from acquired 2D fluoroscopic images. The device allows real-time display of cardiac maps in a number of different formats, including anatomical maps, cardiac electrical activation maps and cardiac voltage maps.

Source page: https://510kreport.com/device/K152160
Methodology: https://510kreport.com/methodology