# K201094: iMap 3D Mapping & Navigation System (iMap System)

- Pathway: 510(k) (Traditional)
- Applicant: Cardionxt, Inc.
- Decided: Aug 16, 2021 after 479 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- 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 K093942 (2010). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160210: EnSite Precision Cardiac Mapping System v2.0, St Jude Medical (2016) Summary page 4.
- K160186: EnSite Velocity Surface Electrode Kit, St Jude Medical (2016) Summary page 4.
- K961924: Ibi-1100 Steerable Electrophysiology Catheter System, Irvine Biomedical, Inc. (1997) Summary page 4.

## Indications for use
The CardioNXT iMap™ 3D Mapping & Navigation System is intended for the display of compatible electrophysiology catheter position and cardiac electrical activity when used with the MultiLink CS Catheter during conventional electrophysiological procedures. The MultiLink CS Catheter is used for electrogram recording and as a navigation reference during conventional electrophysiological procedures.

Source page: https://510kreport.com/device/K201094
Methodology: https://510kreport.com/methodology