# K052704: Model BBD Breast Immobilization and Biopsy Device

- Pathway: 510(k) (Traditional)
- Applicant: Invivo Corp.
- Decided: Nov 3, 2005 after 36 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K071534: Confirma Breast Mri Interventional Components (2007), 0 descendants of its own

## Indications for use
To be used in conjunction with a Magnetic Resonance Scanner to permit MR guided breast biopsy and localization of lesions that can be performed and interpreted by a trained physician.

Source page: https://510kreport.com/device/K052704
Methodology: https://510kreport.com/methodology