# K080820: Tem 3002G- HN Dual Tune Head Coil

- Pathway: 510(k) (Traditional)
- Applicant: Mr Instruments, Inc.
- Decided: Apr 2, 2008 after 9 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 K990550 (1999). 14 ancestors in all.
No later device cites it as a predicate yet.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040444: GE Signa 3.0T with Excite MR System, General Electric Co. (2004) Summary page 2.
- K042617: 31P/1H Headcoil for Magnetom Allegra, Siemens Medical Solutions USA, Inc. (2004) Summary page 2.
- K042718: 13C/1H Occipital Headcoil for Magnetom Allegra, Siemens Medi Cal Solutions, Inc. (2004) Summary page 2.

## Indications for use
The MR Instruments TEM 3002G-HN Dual Tune headcoil is to be used in conjunction with a 3T Magnetic Resonance Imaging system to produce proton ('H) images and spectra of the internal structures of the head. In addition, sodium (23Na) images and spectra may be obtained during the same exam without changing the coil. These images and/or spectral information of the head, when interpreted by a trained physician, may yield information that may assist in diagnosis.

Source page: https://510kreport.com/device/K080820
Methodology: https://510kreport.com/methodology