# K180123: Breast BI 7 MR Coil 1.5T Mammavention

- Pathway: 510(k) (Traditional)
- Applicant: Noras Mri Products GmbH
- Decided: Feb 16, 2018 after 31 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 K082373 (2008). 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)
- K162651: Breast BI 7 MR Coil Mammavention 3T, Moras Mri Products GmbH (2017) Summary page 7.

## Most influential descendants
- K220144: Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T (2022), 0 descendants of its own

## Indications for use
The intended use of Breast BI 7 MR Coil 1.5T Mammavention 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 physican, these images provide information that can be useful in determining diagnosis. The included Breast Biopsy Unit permits MR guided breast biopsy and wire localization of lesions chan be performed by a trained physician. The coil system Breast BI 7 MR Coil Mammavention 1.5T can be used with the following MRI systems: 1.5T: Siemens 1.5T: Avanto fit, Aera, Amira

Source page: https://510kreport.com/device/K180123
Methodology: https://510kreport.com/methodology