# K261119: NorthStar Mapping System (MAP01 or MAP01-01)

- Pathway: 510(k) (Special)
- Applicant: Imricor Medical Systems, Inc.
- Decided: Jun 30, 2026 after 88 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: 20 generations back to K001437 (2000). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K252164: NorthStar™ Mapping System, Imricor Medical Systems (2026) Summary page 6.
- K252794: Vision-MR™ Diagnostic Catheter, Imricor Medical Systems, Inc. (2026) Summary page 6.

## 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. The Vision-MR™ Diagnostic Catheter is intended for cardiac electrophysiological mapping (stimulating and recording) during electrophysiology procedures to diagnose arrhythmias and/or guide therapeutic decisions in adult and pediatric patients.

Source page: https://510kreport.com/device/K261119
Methodology: https://510kreport.com/methodology