# K220144: Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T

- Pathway: 510(k) (Traditional)
- Applicant: Noras Mri Products GmbH
- Decided: Apr 8, 2022 after 79 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 K082373 (2008). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162651: Breast BI 7 MR Coil Mammavention 3T, Moras Mri Products GmbH (2017) Summary page 4.
- K180123: Breast BI 7 MR Coil 1.5T Mammavention, Noras Mri Products GmbH (2018) Summary page 4.

## Indications for use
The intended use of the Breast Coil is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breast. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the female breast. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis. The included Breast Biopsy Unit permits MR guided breast biopsy and placement of localization-wire by a trained physician. For use with Siemens 0.55T, 1.5T, and 3T systems

Source page: https://510kreport.com/device/K220144
Methodology: https://510kreport.com/methodology