# K080120: Hfo Shoulder Coil

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems MR Finland
- Decided: Mar 10, 2008 after 53 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 K040288 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040288: QSC-127-Int Shoulder Array Coil Set, Mri Devices Corp. (2004) Summary page 1.

## Indications for use
The HFO Shoulder Coil is indicated for use in the following anatomic regions and with the designated nuclei: Anatomic Region: Shoulder and adjacent regions Nuclei Excited: Hydrogen The addition of the HFO Shoulder Coil does not change the existing indications for use of the cleared High Field Open (1.0T) Panorama system, as defined below. The High Field Open (1.0T) Panorama 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 (T1), and spin-spin relaxation time (T2), and (3) display the soft tissue structure of the head, extremities and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

Source page: https://510kreport.com/device/K080120
Methodology: https://510kreport.com/methodology