# K190668: Encompass 15 Channel Head Coil, 3T

- Pathway: 510(k) (Traditional)
- Applicant: Qfix
- Decided: Sep 9, 2019 after 178 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: 3 generations back to K013159 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091546: Noras or Head Coil 3T, Models SI7200/SI72100/SI7220/SI7230, Noras Mri Products GmbH (2009) Summary page 5.

## Indications for use
The Encompass™ 15 Channel Head Coil is intended to be used in conjunction with a Magnetic Resonance Scanner for the MR examination of the human brain just before, during, and at the end of brain surgery. The Encompass™ 15 Channel Head Coil can also be used as a standard diagnostic head coil for diagnostic examinations and fMRI (Functional Magnetic Resonance Imaging). When used with magnetic resonance imaging systems, it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.

Source page: https://510kreport.com/device/K190668
Methodology: https://510kreport.com/methodology