510(k) · Cleared
ClearedAlltech Echostar 1.5 T 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 Aug 6, 2008 after a 12-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 4 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Aug 6, 2008
- Review
- 12 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 0
3 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.
- This deviceK082100 Alltech Echostar 1.5 T MR SystemAlltech Medical Systems America, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK113511 Echostar Spica 1.5T MR SystemAlltech Medical Systems America, Inc. · 2012 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK141945 Echostar Comfort 1.5T MriAlltech Medical Systems America, Inc. · 2015
- Descendant · 3 generations on · 0 of its ownK163192 Comfort EC710Alltech Medical Systems America, Inc. · 2017
Class I recalls in this family
- K113511 Echostar Spica 1.5T MR Systemcites it directly · 2012
Most influential descendants
Showing 3 of 3 · See all- K113511Echostar Spica 1.5T MR SystemAlltech Medical Systems America, Inc. · 2012 · cites it directly2descendants
- K141945Echostar Comfort 1.5T MriAlltech Medical Systems America, Inc. · 2015 · 2 generations on1descendant
- K163192Comfort EC710Alltech Medical Systems America, Inc. · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082100 | Alltech Echostar 1.5 T MR System | Alltech Medical Systems America, Inc. | 2008 | — |
| +1 | K113511 | Echostar Spica 1.5T MR System | Alltech Medical Systems America, Inc. | 2012 | Class I |
| +2 | K141945 | Echostar Comfort 1.5T Mri | Alltech Medical Systems America, Inc. | 2015 | — |
| +3 | K163192 | Comfort EC710 | Alltech Medical Systems America, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 1 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113511 | Echostar Spica 1.5T MR System Class I | 2012 | 2 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K113511Echostar Spica 1.5T MR SystemAlltech Medical Systems America, Inc. · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K113511 (Alltech Medical Systems America, Inc., 2012) has gone furthest, with 2 descendants 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. 2008, 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 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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K082100 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082100: Alltech Echostar 1.5 T 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/K082100
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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