# K091546: Noras or Head Coil 3T, Models SI7200/SI72100/SI7220/SI7230

- Pathway: 510(k) (Special)
- Applicant: Noras Mri Products GmbH
- Decided: Jun 24, 2009 after 28 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 K013159 (2001). 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)
- K060758: OR Head Coil 1.5 T, Siemens Medical Solutions USA, Inc. (2006) Summary page 3.
- K013159: HRH-63-8 Head Array Coil, Mri Devices Corp. (2001) Summary page 3.

## Most influential descendants
- K190668: Encompass 15 Channel Head Coil, 3T (2019), 0 descendants of its own

## Indications for use
The intended use of the Noras OR Head Coil 3T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human brain just before, during and at the end of the brain surgery in the operating room. The coil can also be used as a standard diagnostic head coil for diagnostic examinations and fMRI (Functional Magnetic Resonance Imaging). Used in the 3T MAGNETOM Systems, it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.

Source page: https://510kreport.com/device/K091546
Methodology: https://510kreport.com/methodology