# K173290: DuoFLEX Coil Suite

- Pathway: 510(k) (Traditional)
- Applicant: Mr Instruments, Inc.
- Decided: Nov 28, 2017 after 43 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: 3 generations back to K042844 (2004). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130706: Duoflex Coil Suite (1.5T), Mr Instruments, Inc. (2013) Summary page 4.

## Indications for use
The 1.5T GE and Siemens DuoFLEX® Coil Suites and the 3.0T GE and Siemens DuoFLEX® Coil Suites are indicated for use on the order of a physician in conjunction with a 1.5T GE Healthcare and Siemens Healthcare Magnetic Resonance Scanner system and a 3.0T GE Healthcare and Siemens Healthcare Magnetic Resonance Scanner system to produce 2D and 3D images that when interpreted by a trained physician yield information that may assist in diagnosis.

Source page: https://510kreport.com/device/K173290
Methodology: https://510kreport.com/methodology