# K120301: Mediguide Technology

- Pathway: 510(k) (Special)
- Applicant: St. Jude Medical, Mediguide Navigation Systems
- Decided: Feb 24, 2012 after 24 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: 1 generation back to K102905 (2010). 1 ancestor in all.
42 later devices descend from it; 2 cite it directly.
5 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102905: Guided Medical Positioning System II (GMPS II), Mediguide, Ltd. (2010) Summary page 2.

## Most influential descendants
- K160210: EnSite Precision Cardiac Mapping System v2.0 (2016), 29 descendants of its own
- K172396: EnSite Velocity Cardiac Mapping System v5.2 (2018), 27 descendants of its own
- K182644: EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 (2018), 26 descendants of its own
- K183128: EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 (2018), 25 descendants of its own
- K201181: EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System (2020), 18 descendants of its own

## Indications for use
The MediGuide Technology. system is intended for the evaluation of vascular and cardiac anatomy. It is intended to enable real time tip positioning and navigation of a MediGuide enabled (equipped with a MediGuide sensor) diagnostic or therapeutic invasive device used in vascular or cardiac interventions in the Cath Lab environment, on both live fluoroscopy or recorded background. The System is indicated for use as an adjunct to fluoroscopy.

Source page: https://510kreport.com/device/K120301
Methodology: https://510kreport.com/methodology