# K962117: Quadrature and Phased Array Flexible Body Coils

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Aug 27, 1996 after 88 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- 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: 1 generation back to K954190 (1995). 1 ancestor in all.
2 later devices descend 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)
- K954190: Model 580GE-64 Quadrature Abdominal Flex Coil, Medical Advances, Inc. (1995) Summary page 2.

## Most influential descendants
- K984588: Phased Array Flexible Cardiac Coil (1999), 1 descendant of its own
- K031095: Sense Body Coil (2003), 0 descendants of its own

## Indications for use
The Quadrature and Phased Array Flexible Body Coils do not change the intended use of the Picker 1.5T EDGE system. The 1.5T EDGE 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 Quadrature and Phased Array Flexible Body Coils are indicated for use in the following anatomic regions and with the designated nuclei: Anatomic Regions: Liver, kidneys, adrenal glands, spleen, bilateral hips and associated abdominopelvic structures Nuclei Excited: Hydrogen

Source page: https://510kreport.com/device/K962117
Methodology: https://510kreport.com/methodology