# K142002: Breast Speeder CX, Grid Holder CX

- Pathway: 510(k) (Traditional)
- Applicant: Quality Electrodynamics, LLC
- Decided: Aug 22, 2014 after 30 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: 2 generations back to K993776 (1999). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060873: Vanguard Mri Auxiliary Patient Table with 4 and 8 Channel Coil Array for GE Signa Systems, Sentinelle Medical, Inc. (2006) Summary page 5.

## Indications for use
The Breast SPEEDER CX is intended for use with Toshiba 1.5T MRI systems to produce diagnostic images of the breast anatomy that can be interpreted by a trained physician. The Grid Holder CX kit is intended for use with the Breast SPEEDER CX to permit access to the breast anatomy for biopsy and lesion localization procedures.

Source page: https://510kreport.com/device/K142002
Methodology: https://510kreport.com/methodology