# K052200: Tem 3000 Head Coil

- Pathway: 510(k) (Traditional)
- Applicant: Mr Instruments, Inc.
- Decided: Aug 19, 2005 after 7 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). 4 ancestors in all.
No later device cites it as a predicate yet.
1 of 5 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 1.

## Indications for use
The MR Instruments TEM 3000G Head Coil is designed to provide Magnetic Resonance Images of the brain, soft tissues and vasculature of the head. The TEM 3000G Head Coil is designed for use with the GE Signa 3.0T Excite MR System manufactured by GE.

Source page: https://510kreport.com/device/K052200
Methodology: https://510kreport.com/methodology