# K130706: Duoflex Coil Suite (1.5T)

- Pathway: 510(k) (Traditional)
- Applicant: Mr Instruments, Inc.
- Decided: Jul 25, 2013 after 132 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: 2 generations back to K042844 (2004). 2 ancestors in all.
1 later device descends 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)
- K110610: 1.5 GE 6-Channel Phased Array Flex Coil, 3.0 GE 6-Channel Phased Array Flex Coil, Ge Medical Systems, LLC (2011) Summary page 1.

## Most influential descendants
- K173290: DuoFLEX Coil Suite (2017), 0 descendants of its own

## Recalls of this device
- May 23, 2017 · Class II · Z-3067-2017: Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and EG-3870UTK ultrasound gastroscopes. In the disinfection step, the IFU has a warning indicating the clean

## Indications for use
The DuoFLEX Coil Suite is indicate for use on the order of the physician in conjunction with a 1.5T MRI scanner, as an accessory to product 2D and 3D images. The DuoFLEX Coil Suite is for use with GE Healthcare MR Systems.

Source page: https://510kreport.com/device/K130706
Methodology: https://510kreport.com/methodology