# K040937: Tem 3000 Head Coil

- Pathway: 510(k) (Traditional)
- Applicant: Mr Instruments, Inc.
- Decided: Apr 23, 2004 after 11 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: 2 generations back to K002179 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021330: Magnetom Trio Quadrature TX/RX Head Coil, Usa Instruments, Inc. (2002) Summary page 2.
- (no number) USA Instruments 3T head coil: named in the summary without a submission number

## Most influential descendants
- K061281: Insight Head Coil (2006), 0 descendants of its own

## Indications for use
The TEM 3000 head coil is designed to provide Magnetic Resonance Images of the brain, soft tissues and vasculature of the head. The TEM 3000 head coil is designed for use with the Magnetom Trio 3.0 Tesla scanner manufactured by Siemens Medical Systems.

Source page: https://510kreport.com/device/K040937
Methodology: https://510kreport.com/methodology