# K042718: 13C/1H Occipital Headcoil for Magnetom Allegra

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medi Cal Solutions, Inc.
- Decided: Nov 12, 2004 after 43 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 K970852 (1997). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 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.
- K020991: Syngo MR 2002B, Siemens Medical Solutions USA, Inc. (2002) Summary page 2.
- (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 13C/IH occipital headcoil for MAGNETOM Allegra is a transmit/receive surface coil type headcoil double resonant on carbon (13C) and proton (1H) frequencies. Used in the Allegra system it is indicated for use as a diagnostic imaging device to produce 1H images and 1H spectra of the internal structures of the head. In addition, 13C 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 (T1), spin-spin echo time (T2) and resonance frequency 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/K042718
Methodology: https://510kreport.com/methodology