FDA.reportPublic FDA data

510(k) K261119

Device
NorthStar Mapping System (MAP01 or MAP01-01)
Applicant
Imricor Medical Systems, Inc.
510(k) number
K261119
Product code
DQK
Decision
Substantially Equivalent (SESE)
Decision date
2026-06-30
Date received
2026-04-03
Regulation
870.1425
Classification name
Computer, Diagnostic, Programmable
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Oksana Alswager
Address
400 Gateway Blvd. Burnsville MN US 55337 55337

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DQK#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253463ILR ECG Analyzer (IM007)Implicity, Inc.2026-07-02
K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.2026-06-12
K261329Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035)Centerline Biomedical2026-06-10
K252859ZEUS Platform (FG0501US)iRhythm Technologies, Inc.2026-05-29
K260212EnSite™ X EP SystemABBOTT MEDICAL2026-04-20
K253861ACORYS MAPPING SYSTEMCorify Care S.L2026-04-13
K253473SynchronyStereotaxis, Inc.2026-04-01
K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC2026-02-24
K252972CARTO™ 3 EP Navigation System V8.4Biosense Webster, Inc.2026-02-20
K254089IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035)Centerline Biomedical, Inc.2026-02-17
K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc.2026-02-09
K251218SafeBeat Rx AppSafeBeat Rx, Inc.2026-02-06
K252164NorthStar™ Mapping SystemImricor Medical Systems2026-01-28
K254085CARTO™ 3 EP Navigation System V9.0 with PIU PlusBiosense Webster, Inc.2026-01-18
K253733STAR Apollo™ Mapping SystemRhythm AI, Ltd.2025-12-19