# K110591: MC 1504G-16R, 1.5T, 16-Channel, MC 3004G-16R, 3.0T, 16-Channel Head Coil

- Pathway: 510(k) (Traditional)
- Applicant: Mr Instruments, Inc.
- Decided: Mar 29, 2011 after 27 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 K013159 (2001). 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)
- K013159: HRH-63-8 Head Array Coil, Mri Devices Corp. (2001) Summary page 1.
- K022372: HRH-127-8 Head Array Coil, Mri Devices Corp. (2002) Summary page 1.

## Indications for use
This coil is indicate for use in conjunction with 1.5T and 3.0T GE Healthcare Magnetic Resonance Scanner systems to produce images and/or spectra of the head, that when interpreted by a trained physician yield information that may assist in diagnosis.

Source page: https://510kreport.com/device/K110591
Methodology: https://510kreport.com/methodology