# K101492: 8 Channel Cardiac Phased Array Coil

- Pathway: 510(k) (Traditional)
- Applicant: Ge Healthcare Coils (Usa Instruments, Inc.)
- Decided: Jun 23, 2010 after 22 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
Longest line of descent: 4 generations back to K971667 (1997). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032045: 8 Channel Cardiac Phased Array Coil, GE Medical Systems (2003) Summary page 1.
- K052584: 1.5T 12 Channel Body Array, Usa Instruments, Inc. (2005) Summary page 2.

## Indications for use
The 8 Channel Cardiac Phased Array Coil is a receive-only RF Coil designed for use with 1.5T MRI systems manufactured by GE Healthcare. The indications for use include imaging of the heart, mediastinum, and pelvis regions for 2D and 3D Magnetic Resonance imaging. The nucleus excited is hydrogen.

Source page: https://510kreport.com/device/K101492
Methodology: https://510kreport.com/methodology