510(k) · Cleared
ClearedGyrex Prima 1TG 1.0T Mri System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elscint Mr, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Aug 25, 1997 after a 160-day review. The FDA summary names its predicate without a number. 53 later devices descend from it.
- Decided
- Aug 25, 1997
- Review
- 160 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 0
53 later devices descend from it, 3 citing it directly.
- This deviceK970990 Gyrex Prima 1TG 1.0T Mri SystemElscint Mr, Inc. · 1997
- Descendant · cites it directly · 50 of its ownK981358 Artoscan SBiosound Esaote, Inc. · 1998
- Descendant · 2 generations on · 49 of its ownK990968 E-SCANBiosound Esaote, Inc. · 1999
- Descendant · 3 generations on · 48 of its ownK020164 E-Scan XQBiosound Esaote, Inc. · 2002
- Descendant · 3 generations on · 47 of its ownK032121 Modification to E-Scan XQEsaote, S.p.A. · 2003
- Descendant · 4 generations on · 45 of its ownK042236 G-SCANEsaote, S.p.A. · 2004
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 53 · See all- K981358Artoscan SBiosound Esaote, Inc. · 1998 · cites it directly50descendants
- K990968E-SCANBiosound Esaote, Inc. · 1999 · 2 generations on49descendants
- K020164E-Scan XQBiosound Esaote, Inc. · 2002 · 3 generations on48descendants
- K032121Modification to E-Scan XQEsaote, S.p.A. · 2003 · 3 generations on47descendants
- K042236G-SCANEsaote, S.p.A. · 2004 · 4 generations on45descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970990 | Gyrex Prima 1TG 1.0T Mri System | Elscint Mr, Inc. | 1997 | — |
| +1 | K981358 | Artoscan S | Biosound Esaote, Inc. | 1998 | — |
| +2 | K990968 | E-SCAN | Biosound Esaote, Inc. | 1999 | — |
| +3 | K020164 | E-Scan XQ | Biosound Esaote, Inc. | 2002 | — |
| +3 | K032121 | Modification to E-Scan XQ | Esaote, S.p.A. | 2003 | — |
| +4 | K042236 | G-SCAN | Esaote, S.p.A. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 7 | 0 |
| 2013 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2019 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 3 | 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.
Planning a device in LNH? 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 |
|---|---|---|---|
| * | — | Prestige 2.0T MRI System Named without a submission number |
What descends from it? (53)
See all 533 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K981358 (Biosound Esaote, Inc., 1998) has gone furthest, with 50 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.
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 Gyrex Prima 1TG 1.0T MRI system is a general purpose whole-body MRI system that
produces images of the internal structures of the head, body, or extremities. The indications for
use are not dissimilar to established indications for use for other general purpose whole-body
MRI systems. The established indications for use are that when interpreted by a trained
physician, MRI can be useful in determination of a diagnosis, surgery planning, or therapy
planning and is used in a clinic or hospital setting.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970990 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970990: Gyrex Prima 1TG 1.0T Mri System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970990
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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