# K163192: Comfort EC710

- Pathway: 510(k) (Traditional)
- Applicant: Alltech Medical Systems America, Inc.
- Decided: Apr 10, 2017 after 146 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- 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 K082100 (2008). 3 ancestors in all.
No later device cites it as a predicate yet.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141945: Echostar Comfort 1.5T Mri, Alltech Medical Systems America, Inc. (2015) Summary page 4.

## Indications for use
The Comfort EC710 is a whole-body magnetic resonance imaging (MRI) system intended for general diagnostic use. Transverse, sagittal, coronal and oblique planes may be imaged. MRI images produced by the Comfort EC710 system reflect the spatial distribution for the density of hydrogen nuclei (protons) spin-lattice relaxation time (T1). spin-spin relaxation time (T2) and flow, When interpreted by a tramed physician. these images yield information that can be useful in the determining of a diagnosis.

Source page: https://510kreport.com/device/K163192
Methodology: https://510kreport.com/methodology