# K122646: DS Breast 16CH I/T 1.5T DS Breast 16CH I/T 3.0T

- Pathway: 510(k) (Traditional)
- Applicant: Invivo Corporation
- Decided: Nov 2, 2012 after 64 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: 1 generation back to K032576 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032576: Biopsy Breast Coil, Model BBC, Mri Devices Corp. (2003) Summary page 1.
- K041481: Model BBC-127 Biopsy Breast Coil, Mri Devices Corp. (2004) Summary page 1.

## Indications for use
The coil is indicated for use on the order of a physician, in conjunction with Philips 1.5T and 3.OT MR scanners as an accessory to produce images of the breast, chest wall and axillary tissue, as an aid to diagnosis. The coil permits MR-guided breast biopsy and localization of lesions.

Source page: https://510kreport.com/device/K122646
Methodology: https://510kreport.com/methodology