# K991765: Synergy Shoulder Coil

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America, Inc.
- Decided: Aug 2, 1999 after 70 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 K963990 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980645: Philips Gyroscan NT Release 6 Series, Philips Medical Systems North America, Inc. (1998) Summary page 1.

## Indications for use
Due to its shape and size the RF external Synergy Shoulder coil allows a variety of applications but with the main purpose of optimal imaging of the shoulder structure. It is compatible to be used with the Philips GYROSCAN NT systems which are indicated for use as diagnostic devices that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, based upon 'H and 31p metabolites, and that display the internal structure and/or function of the head, body or extremities. These images and/or spectra when interpreted by a trained physician, yield information that may assist in diagnosis.

Source page: https://510kreport.com/device/K991765
Methodology: https://510kreport.com/methodology