# K050476: Cordless Coil

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solution, Inc. USA
- Decided: Mar 25, 2005 after 29 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 K970852 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003192: Magnetic Concerto, Siemens Medical Solutions USA, Inc. (2000) Summary page 2.
- K043030: Magnetom C! MR System, Siemens Medical Solutions (2004) Summary page 2.

## Indications for use
The Cordless coil is a receive type surface coil. When used in the MAGNETOM Concerto and C! MR systems, it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of internal structures of the brain and body surface. The images produced reflect the spatial distribution of protons exhibiting magnetic resonance. Spectra allow the molecules containing the nucleus under investigation to be distinguished. The NMR properties that determine the image and spectra appearance are spin density, spin-lattice relaxation time (TI), and the 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 making diagnoses.

Source page: https://510kreport.com/device/K050476
Methodology: https://510kreport.com/methodology