# K061715: Mrgfus General Purpose and Breast Coil

- Pathway: 510(k) (Traditional)
- Applicant: Insightec Txsonics, Inc.
- Decided: Jul 28, 2006 after 39 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: 5 generations back to K893619 (1989). 22 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030953: GE 3.0T General Purpose Flex Coil, Ge Medical Systems, Inc. (2003) Summary page 2.
- K033753: Pelvic Array Coil, Usa Instruments, Inc. (2003) Summary page 2.
- K052585: 3T HD Breast Array, Usa Instruments, Inc. (2005) Summary page 2.
- P830074: GE Signa Magnetic Resonance Diagnostic Imaging Sys, General Electric Co.. FDA lists this PMA only through its supplements; the earliest we hold is P830074/S001 (Sep 10, 1985). Summary page 2.

## Cited in the summary but kept off the family tree
- K982001: Medrad Breast Coil. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K083434: TT1 General Purpose Coil (2008), 1 descendant of its own
- K113280: Carotid Coil GE 1.5T (2011), 0 descendants of its own

## Indications for use
The MRgFUS General Purpose and Breast Coil (the MRgFUS Coil) is a receive only RF coil, designed for MR imaging of the breast and auxiliary tissue and of a variety of medium-sized anatomical regions, such as spine, neck, shoulder, thigh, foot ankle and joints. The MRgFUS Coil is designed for use with the GE Signa TM (1.5T or 3.0T) MRI systems manufactured by GE Medical Systems.

Source page: https://510kreport.com/device/K061715
Methodology: https://510kreport.com/methodology