# K072909: 1.5T 32-Channel Head Coil and 3T 32-Channel Head Coil

- Pathway: 510(k) (Traditional)
- Applicant: Siemens AG Medical Solutions
- Decided: Oct 31, 2007 after 19 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 K971684 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032428: Magnetom Avanto MR System, Siemens Medical Solutions USA, Inc. (2003) Summary page 2.
- K050200: Magnetom Trio a Tim System, Siemens Medical Solutions USA, Inc. (2005) Summary page 2.

## Indications for use
The intended uses of the 1.5T 32-channel Head Coil and the 3T 32-channel Head Coil are, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human head. Used in the 1.5 T MAGNETOM Avanto, MAGNETOM Espree or MAGNETOM Symphony, a Tim System, the 1.5 T 32-channel Head Coil and in the 3 T MAGNETOM Trio, a Tim System, the 3T 32-channel Head Coil are indicated for uses as a diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the body. The images produced by the 1.5 T MAGNETOM Avanto, MAGNETOM Espree or MAGNETOM Symphony, a Tim System with the 1.5 T 32-channel Head Coil and the images produced by the 3 T MAGNETOM trio a Tim System with the 3T 32-channel Head Coil reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. The intended use of the MAGNETOM Avanto, MAGNETOM Espree or MAGNETOM Symphony a Tim System is not affected in any way by the use of the new 1.5T 32-channel Head Coil. The intended use of the MAGNETOM Trio a Tim System is not affected in any way by the use of the new 3T 32-channel Head Coil.

Source page: https://510kreport.com/device/K072909
Methodology: https://510kreport.com/methodology