# K963356: Phased Array Shoulder Coil

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Nov 22, 1996 after 88 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: 1 generation back to K945778 (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)
- K945778: Phased Array Shoulder Coil, Quadrature Shoulder Coil, Medical Advances, Inc. (1995) Summary page 2.

## Most influential descendants
- K083578: Noras CPC Multifunctional Coil (2009), 1 descendant of its own
- K140252: 16 CH Multipurpose Coil Variety (2014), 0 descendants of its own

## Indications for use
The Phased Array Shoulder Coil does not change the intended use of the Picker 1.5 T EDGE system. The 1.5 T 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 dete;mination of a diagnosis. The Phased Array Shoulder Coil is indicated for use in the following anatomic regions and with the designated nuclei: Anatomic Regions: Shoulder and other related joint structures Nuclei Excited: Hydrogen

Source page: https://510kreport.com/device/K963356
Methodology: https://510kreport.com/methodology