Guided Medical Positioning System (GMPS)

FDA 510(k) K091781 · Mediguide, Ltd.

Substantially Equivalent

510(k) numberK091781

Submission

Device name
Guided Medical Positioning System (GMPS)
Applicant
Mediguide, Ltd.
Washington, DC, US
Received
June 17, 2009
Decision date
October 16, 2009
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DQK – Computer, Diagnostic, Programmable
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1425
Specialty
Cardiovascular

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K261119NorthStar Mapping System (MAP01 or MAP01-01)DQK · Special Imricor Medical Systems, Inc.06/30/2026SE
K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)DQK · Traditional Micropace Pty, Ltd.06/12/2026SE
K261329Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…DQK · Special Centerline Biomedical06/10/2026SE
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More from iRhythm Technologies, Inc.

510(k)DeviceDecision
K102905Guided Medical Positioning System II (GMPS II)DQK · Special 10/29/2010SE
K091780Guided Measurement Catheter (GMC)DQO · Traditional 10/16/2009SE

Questions and answers

When was Guided Medical Positioning System (GMPS) cleared by the FDA?

Guided Medical Positioning System (GMPS) (K091781) received a 510(k) decision of Substantially Equivalent on October 16, 2009, 121 days after the submission was received.

What is the product code of K091781?

The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.