# K082100: Alltech Echostar 1.5 T MR System

- Pathway: 510(k) (Traditional)
- Applicant: Alltech Medical Systems America, Inc.
- Decided: Aug 6, 2008 after 12 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
No predicates in its family tree.
3 later devices descend 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K113511: Echostar Spica 1.5T MR System (2012), 2 descendants of its own
- K141945: Echostar Comfort 1.5T Mri (2015), 1 descendant of its own
- K163192: Comfort EC710 (2017), 0 descendants of its own

## Indications for use
The EchoStar 1.5 T MR System is a whole-body magnetic resonance imaging (MRI) system intended for general diagnostic use. Sagittal, coronal and oblique [text illegible] be imaged. MRI images produced by the EchoStar system reflect the spatial distribution of hydrogen nuclei (protons), spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and fluid flow. When interpreted by a trained physician, these images yield information that can be useful in the determining of a diagnosis. This device is intended for prescription use only.

Source page: https://510kreport.com/device/K082100
Methodology: https://510kreport.com/methodology