510(k) · Cleared
Recalled · Class I · 2015Echostar Spica 1.5T MR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alltech Medical Systems America, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on May 2, 2012 as substantially equivalent to K082100 (Alltech Medical Systems America, Inc., 2008) after a 156-day review. Its family tree reaches back 1 generation to 2008. 1 of the 4 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- May 2, 2012
- Review
- 156 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K082100 (2008). 2 later devices descend from it, 1 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK082100 Alltech Echostar 1.5 T MR SystemAlltech Medical Systems America, Inc. · 2008
- This deviceK113511 Echostar Spica 1.5T MR SystemAlltech Medical Systems America, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK141945 Echostar Comfort 1.5T MriAlltech Medical Systems America, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK163192 Comfort EC710Alltech Medical Systems America, Inc. · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K082100 | Alltech Echostar 1.5 T MR System | Alltech Medical Systems America, Inc. | 2008 | — |
| 0 (this device) | K113511 | Echostar Spica 1.5T MR System | Alltech Medical Systems America, Inc. | 2012 | — |
| +1 | K141945 | Echostar Comfort 1.5T Mri | Alltech Medical Systems America, Inc. | 2015 | — |
| +2 | K163192 | Comfort EC710 | Alltech Medical Systems America, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LNH device
- #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K082100 | Alltech Echostar 1.5 T MR SystemSummary page 1…uivalent through the 510O(k) premarket notification process, the Alltech EchoStar 1.5 T. The Ailtech EchoStar 1.5 T. was cleared by the FDA on August 06, 2008 (K082100). (4) Device Description The Echostar Spica 1.5 T MR System represents a modification to the previously cleared Echo… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141945 | Echostar Comfort 1.5T Mri | 2015 | 1 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 9, 2015 | Class I | Z-1061-2015 | Process control | The MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K141945 (Alltech Medical Systems America, Inc., 2015) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LNH devicesLNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · LNH
26in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNH
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNH
8in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · LNH
1,263in 2025
MAUDE reports naming product code LNH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 35 | 25 | 114 |
| 2008 | 19 | 53 | 12 | 167 |
| 2009 | 17 | 70 | 7 | 194 |
| 2010 | 12 | 94 | 17 | 165 |
| 2011 | 16 | 81 | 11 | 182 |
| 2012 | 22 | 89 | 5 | 170 |
| 2013 | 19 | 108 | 2 | 107 |
| 2014 | 17 | 108 | 13 | 119 |
| 2015 | 19 | 140 | 12 (2) | 113 |
| 2016 | 20 | 108 | 1 | 135 |
| 2017 | 18 | 98 | 0 | 121 |
| 2018 | 29 | 128 | 71 | 158 |
| 2019 | 26 | 62 | 5 | 158 |
| 2020 | 32 | 121 | 4 | 98 |
| 2021 | 27 | 87 | 41 | 84 |
| 2022 | 30 | 74 | 13 | 138 |
| 2023 | 30 | 124 | 10 (1) | 159 |
| 2024 | 26 | 104 | 4 | 281 |
| 2025 | 26 | 122 | 8 (5) | 1,263 |
| 2026 | 24 | 126 | 43 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113511 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113511: Echostar Spica 1.5T MR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113511
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026