# K041481: Model BBC-127 Biopsy Breast Coil

- Pathway: 510(k) (Special)
- Applicant: Mri Devices Corp.
- Decided: Jul 19, 2004 after 46 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
232 later devices descend from it; 4 cite it directly.
19 of 233 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
- K060873: Vanguard Mri Auxiliary Patient Table with 4 and 8 Channel Coil Array for GE Signa Systems (2006), 229 descendants of its own
- K100113: Vanguard Breast Mri Auxiliary Table with 16 Channel Coil Array for GE 3T Mri System, Model 4000451-51 (2010), 227 descendants of its own
- K111242: Magnetom Aera and Magnetom Skyra (2011), 220 descendants of its own
- K121434: Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio (2012), 215 descendants of its own
- K141977: Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo MR E11A, Magnetom Skyra with 24 RF Channel (2014), 115 descendants of its own

## Recalls of this device
- Nov 4, 2024 · Class II · Z-0546-2025: 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/K041481
Methodology: https://510kreport.com/methodology