# K141945: Echostar Comfort 1.5T Mri

- Pathway: 510(k) (Traditional)
- Applicant: Alltech Medical Systems America, Inc.
- Decided: Feb 3, 2015 after 201 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: 2 generations back to K082100 (2008). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113511: Echostar Spica 1.5T MR System, Alltech Medical Systems America, Inc. (2012) Summary page 4.

## Most influential descendants
- K163192: Comfort EC710 (2017), 0 descendants of its own

## Indications for use
The Echostar Comfort 1.5T MRI System 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 Echostar Comfort 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 trained physician, these images yield information that can be useful in the determining of a diagnosis.

Source page: https://510kreport.com/device/K141945
Methodology: https://510kreport.com/methodology