# K252164: NorthStar™ Mapping System

- Pathway: 510(k) (Traditional)
- Applicant: Imricor Medical Systems
- Decided: Jan 28, 2026 after 202 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: 19 generations back to K001437 (2000). 30 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231207: CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U), Biosense Webster, Inc. (2023) Summary page 5.

## Most influential descendants
- K261119: NorthStar Mapping System (MAP01 or MAP01-01) (2026), 0 descendants of its own

## Indications for use
The NorthStar Mapping System is intended to aid interventional Cardiovascular Magnetic Resonance Imaging (iICMRI) procedures, including electrophysiology procedures, by providing a 3D environment in which MR images, devices, and procedure-related data are displayed.

Source page: https://510kreport.com/device/K252164
Methodology: https://510kreport.com/methodology