# K110610: 1.5 GE 6-Channel Phased Array Flex Coil, 3.0 GE 6-Channel Phased Array Flex Coil

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems, LLC
- Decided: Apr 1, 2011 after 29 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
Longest line of descent: 1 generation back to K042844 (2004). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042844: GE Signa Excite 1.5T 6 Channel Phased Array Flex Coil, GE Signa Excite 3.0T 6 Channel Phased Array Flex Coil, Ge Medical Systems, Inc. (2004) Summary page 2.

## Most influential descendants
- K130706: Duoflex Coil Suite (1.5T) (2013), 1 descendant of its own
- K173290: DuoFLEX Coil Suite (2017), 0 descendants of its own

## Recalls of this device
- Dec 7, 2015 · Class II · Z-0553-2016: Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious patient thermal injury. There have been no injuries reported as a result of this issue.

## Indications for use
The 1.5T GE 6-Channel Phased Array Flex Coil is indicated for use on the order of the physician in conjunction with a 1.5T MRI scanner, as an accessory to produce 2D and 3D images. The 3.0T GE 6-Channel Phased Array Flex Coil is indicated for use on the order of the physician in conjunction with a 3.0T MRI scanner, as an accessory to produce 2D and 3D images.

Source page: https://510kreport.com/device/K110610
Methodology: https://510kreport.com/methodology