# K033662: Synergy Spine Array Coil

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems, Inc.
- Decided: Feb 2, 2004 after 73 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Integrated Spine Array (ISA) coil for Philips Infinion 1.5T system: named in the summary without a submission number

## Indications for use
The Synergy Spine Array Coil does not change the existing indications as defined below. The Panorama 0.6T MR Imaging System is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T I), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interprete by a trained physician, thes images yield informationthat can be useful in the determination of a diagnosis. The Synergy Spine Array Coil is indicated for use in the following anatomic regions and with designated nuclei: Anatomic Regions: Thoracic and lumbar Nuclei Excited: Hydrogen

Source page: https://510kreport.com/device/K033662
Methodology: https://510kreport.com/methodology