# K162643: MediGuide Technology System

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: Dec 13, 2016 after 82 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: 2 generations back to K102905 (2010). 2 ancestors in all.
11 later devices descend from it; 2 cite it directly.
5 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120301: Mediguide Technology, St. Jude Medical, Mediguide Navigation Systems (2012) Summary page 4.

## Most influential descendants
- K190106: Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle (2019), 6 descendants of its own
- K230309: Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1) (2023), 5 descendants of its own
- K242133: Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle) (2024), 3 descendants of its own
- K241243: Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters) (2024), 3 descendants of its own
- K201081: AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter (2020), 3 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™/Sensor Enabled™ (equipped with a magnetic sensor) 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/K162643
Methodology: https://510kreport.com/methodology