# K162651: Breast BI 7 MR Coil Mammavention 3T

- Pathway: 510(k) (Traditional)
- Applicant: Moras Mri Products GmbH
- Decided: Jan 18, 2017 after 117 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: 1 generation back to K082373 (2008). 1 ancestor in all.
2 later devices descend from it; 2 cite 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)
- K082373: Noras MR-BI320-PA 3T, Noras Mri Products GmbH (2008) Summary page 8.

## Most influential descendants
- K180123: Breast BI 7 MR Coil 1.5T Mammavention (2018), 1 descendant of its own
- 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 3T 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, ad 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 wire localization of lesions can be performed by a trained physician. The coil system Breast BI 7 MR Coil Mammavention 3T can be used with the following MRI systems: 3T: Siemens 3T: Skyra, Skyra fit, Prisma, Prisma fit, Spectra

Source page: https://510kreport.com/device/K162651
Methodology: https://510kreport.com/methodology