# K032576: Biopsy Breast Coil, Model BBC

- Pathway: 510(k) (Special)
- Applicant: Mri Devices Corp.
- Decided: Oct 23, 2003 after 64 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
21 later devices descend from it; 4 cite it directly.
0 of 22 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
- K041286: Dynacad V1.0 (2004), 17 descendants of its own
- K081556: Cadstream, Version 5.0 (2009), 9 descendants of its own
- K092954: Cadstream Version 5 (2009), 8 descendants of its own
- K170195: QuantX (2017), 4 descendants of its own
- K210670: BU-CAD (2021), 3 descendants of its own

## Recalls of this device
- Nov 4, 2024 · Class II · Z-0536-2025: Potential safety issue where a patient may be harmed while preparing for or during a scan.
- Nov 4, 2024 · Class II · Z-0539-2025: Potential safety issue where a patient may be harmed while preparing for or during a scan.
- Nov 4, 2024 · Class II · Z-0542-2025: Potential safety issue where a patient may be harmed while preparing for or during a scan.
- Nov 4, 2024 · Class II · Z-0540-2025: Potential safety issue where a patient may be harmed while preparing for or during a scan.

## Indications for use
To be used in conjunction with a Magnetic Resonance Scanner to: 1) Produce diagnostic images of the female breast, chest wall, and axillary tissues that can be interpreted by a trained physician. 2) 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/K032576
Methodology: https://510kreport.com/methodology