# K971667: Cardiac Phased Array Coil

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Jul 23, 1997 after 78 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.
7 later devices descend from it; 2 cite it directly.
0 of 8 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) ScanMed Cardiac/Vascular Coil: named in the summary without a submission number
- (no number) GE Pelvic Phased Array Coil: named in the summary without a submission number

## Most influential descendants
- K022669: 8 Channel Cardiac Phased Array Coil (2002), 5 descendants of its own
- K030495: 3.0T Torso Phased Array Coil (2003), 4 descendants of its own
- K031209: GE 1.5T 8 Channel Torso Coil (2003), 3 descendants of its own
- K052584: 1.5T 12 Channel Body Array (2005), 1 descendant of its own
- K032045: 8 Channel Cardiac Phased Array Coil (2003), 1 descendant of its own

## Indications for use
It is intended to be used in the heart and mediastinum regions for 2D and 3D Magnetic Resonance imaging

Source page: https://510kreport.com/device/K971667
Methodology: https://510kreport.com/methodology