# K081118: Noras MR-BI320-PA 1.5T

- Pathway: 510(k) (Traditional)
- Applicant: Noras Mri Products GmbH
- Decided: May 2, 2008 after 11 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 K010570 (2001). 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)
- K002602: Obc-63 Mebreast Array Coil, Mri Devices Corp. (2000) Summary page 4.
- K010570: Breast Immobiization and Biopsy Device MR-Biopsy 160, Mri Devices Corp. (2001) Summary page 4.
- K052987: Breast Immobilization and Biopsy Device, Models BI 160-O, BI 160-PA and BI 160-CC, Noras Rontgen-Und Medizintechnik GmbH (2005) Summary page 4.

## Indications for use
The intended use of the Noras MR-BI320-PA 1.5T 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 BI160-2 permits MR guided breast biopsy, wire localization of lesions that can be performed by a trained physician.

Source page: https://510kreport.com/device/K081118
Methodology: https://510kreport.com/methodology