# K113511: Echostar Spica 1.5T MR System

- Pathway: 510(k) (Traditional)
- Applicant: Alltech Medical Systems America, Inc.
- Decided: May 2, 2012 after 156 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K082100 (2008). 1 ancestor in all.
2 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)
- K082100: Alltech Echostar 1.5 T MR System, Alltech Medical Systems America, Inc. (2008) Summary page 1.

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

## Recalls of this device
- Jan 9, 2015 · Class I · Z-1061-2015: The MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly.

## Indications for use
The Echostar Spica 1.5T MR 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 Spica system reflect the spatial distribution to the density of hydrogen nuclei (protons) spin-lattice relaxation time (Ti), 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. This device is intended for prescription use only.

Source page: https://510kreport.com/device/K113511
Methodology: https://510kreport.com/methodology