# K984588: Phased Array Flexible Cardiac Coil

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Feb 8, 1999 after 46 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: 2 generations back to K954190 (1995). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962117: Quadrature and Phased Array Flexible Body Coils, Philips Medical Systems (Cleveland), Inc. (1996) Summary page 2.

## Most influential descendants
- K031095: Sense Body Coil (2003), 0 descendants of its own

## Indications for use
The Phased Array Flexible Cardiac Coil does not change the intended use of the Picker 1.5T EDGE ECLIPSE system. The 1.5T EDGE ECLIPSE system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis. The Phased Array Flexible Cardiac Coil is indicated for use in the following anatomic regions and with the designated nuclei: Anatomic Regions: Heart and associated structures in the thoracic region. Nuclei Excited: Hydrogen.

Source page: https://510kreport.com/device/K984588
Methodology: https://510kreport.com/methodology