# K052987: Breast Immobilization and Biopsy Device, Models BI 160-O, BI 160-PA and BI 160-CC

- Pathway: 510(k) (Special)
- Applicant: Noras Rontgen-Und Medizintechnik GmbH
- Decided: Nov 8, 2005 after 15 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- 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 K010570 (2001). 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)
- K010570: Breast Immobiization and Biopsy Device MR-Biopsy 160, Mri Devices Corp. (2001) Summary page 1.

## Most influential descendants
- K081118: Noras MR-BI320-PA 1.5T (2008), 0 descendants of its own
- K071534: Confirma Breast Mri Interventional Components (2007), 0 descendants of its own

## Indications for use
The Breast Immobilization and Biopsy Device Models BI 160-0, BI 160-PA, and BI 160-CC are used in conjunction with a Magnetic Resonance Scanner to permit MR guided breast biopsy and wire localization of lesions that can be performed and interpreted by a trained physician.

Source page: https://510kreport.com/device/K052987
Methodology: https://510kreport.com/methodology