# K042617: 31P/1H Headcoil for Magnetom Allegra

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 5, 2004 after 42 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 K962627 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962627: Clinical Phosphorus Spectroscopy Option/Magnetom Vision System, Siemens Medical Solutions USA, Inc. (1997) Summary page 2.
- (no number) 31P/1H heart/liver coil included in syngo MR 2002B: named in the summary without a submission number
- (no number) Signa 1.5T Phosphorus Transmit/Receive Flex Coil: named in the summary without a submission number

## Most influential descendants
- K080820: Tem 3002G- HN Dual Tune Head Coil (2008), 0 descendants of its own

## Indications for use
The 31P/1H headcoil for MAGNETOM Allegra is a transmit/receive birdcage type headcoil double resonant on phosphorus (31 P) and proton (I H) frequencies. Used in the Allegra system it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique I H images and 1H spectra of the internal structures of the head. In addition, 31 P spectra can be obtained within the same session without changing the coil. The images produced reflect the spatial distribution of protons exhibiting magnetic resonance. Spectra allow the molecules, in which the nucleus under investigation is contained, to be distinguished. The NMR properties that determine the image and spectra appearance are spin density, spin-lattice relaxation time (Tl), spin-spin echo time (T2) of the corresponding nucleus. When interpreted by a trained physician, these images and spectra provide information that can be useful in determining diagnosis.

Source page: https://510kreport.com/device/K042617
Methodology: https://510kreport.com/methodology