# K013810: Cardiovascular Array

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Nov 27, 2001 after 12 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) GE Cardiac Array: named in the summary without a submission number

## Most influential descendants
- K031089: Gore-Flex MP8 Multipurpose Torso Array (2003), 0 descendants of its own

## Indications for use
The Cardiovasculax Arxrray is intended for multiple imaging applications with GE Signa(R) 1.5T MRI Systems. Its large field of view will allow for images of the complete thorax, including the heart, aand its associated vasculature, the abdomen, pelvis and spine. A specialized sub-arxay will provide high resolution images of the thoracic region,

Source page: https://510kreport.com/device/K013810
Methodology: https://510kreport.com/methodology