510(k) · Cleared
ClearedMRopen EVO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asg Superconductors S.P.A. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Dec 20, 2019 as substantially equivalent to K190524 (Asg Superconductors S.P.A., 2019) after a 38-day review. Its family tree reaches back 14 generations to 1991. 1 later device descends from it.
- Decided
- Dec 20, 2019
- Review
- 38 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K911667 (1991). 59 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 14 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 10 generations between
- 3 generations backK121249 Multiarray KitParamed S.R.L. · 2012
- 2 generations backK122034 MRJ 3300Paramed S.R.L. · 2012
- 1 generation backK190524 MRopen 0.5 TAsg Superconductors S.P.A. · 2019
- This deviceK193116 MRopen EVOAsg Superconductors S.P.A. · 2019
- Descendant · cites it directly · 0 of its ownK242258 MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)Asg Superconductors S.P.A. · 2024
Show all 14 generations
- Root · 14 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 13 generations backK963262 Artoscan MBiosound, Inc. · 1997
- 12 generations backK981358 Artoscan SBiosound Esaote, Inc. · 1998
- 11 generations backK990968 E-SCANBiosound Esaote, Inc. · 1999
- 10 generations backK020164 E-Scan XQBiosound Esaote, Inc. · 2002
- 9 generations backK032121 Modification to E-Scan XQEsaote, S.p.A. · 2003
- 8 generations backK042236 G-SCANEsaote, S.p.A. · 2004
- 7 generations backK060956 G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006
- 6 generations backK063207 S-Scan Mri SystemEsaote, S.p.A. · 2006
- 5 generations backK080098 MRJ ExtendedParamed S.R.L. · 2008
- 4 generations backK100164 MR Inspire with Extended KitParamed S.R.L. · 2010
- 3 generations backK121249 Multiarray KitParamed S.R.L. · 2012
- 2 generations backK122034 MRJ 3300Paramed S.R.L. · 2012
- 1 generation backK190524 MRopen 0.5 TAsg Superconductors S.P.A. · 2019
- This deviceK193116 MRopen EVOAsg Superconductors S.P.A. · 2019
Most influential descendants
Showing 1 of 1 · See all- K242258MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)Asg Superconductors S.P.A. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K911667 | Hitachi MRP-7000 Magnetic Rosonance Device | Hitachi Medical Systems America, Inc. | 1991 | 2 |
| −13 | K963262 | Artoscan M | Biosound, Inc. | 1997 | — |
| −12 | K981358 | Artoscan S | Biosound Esaote, Inc. | 1998 | — |
| −11 | K990968 | E-SCAN | Biosound Esaote, Inc. | 1999 | — |
| −10 | K020164 | E-Scan XQ | Biosound Esaote, Inc. | 2002 | — |
| −9 | K032121 | Modification to E-Scan XQ | Esaote, S.p.A. | 2003 | — |
| −8 | K042236 | G-SCAN | Esaote, S.p.A. | 2004 | — |
| −7 | K060956 | G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan… | Esaote, S.p.A. | 2006 | — |
| −6 | K063207 | S-Scan Mri System | Esaote, S.p.A. | 2006 | — |
| −5 | K080098 | MRJ Extended | Paramed S.R.L. | 2008 | — |
| −4 | K100164 | MR Inspire with Extended Kit | Paramed S.R.L. | 2010 | — |
| −3 | K121249 | Multiarray Kit | Paramed S.R.L. | 2012 | — |
| −2 | K122034 | MRJ 3300 | Paramed S.R.L. | 2012 | — |
| −1 | K190524 | MRopen 0.5 T | Asg Superconductors S.P.A. | 2019 | — |
| 0 (this device) | K193116 | MRopen EVO | Asg Superconductors S.P.A. | 2019 | — |
| +1 | K242258 | MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) | Asg Superconductors S.P.A. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 4 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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.
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 |
|---|---|---|---|
| * | K190524 | MRopen 0.5 TSummary page 7…0/2020 Indications for Use Soo PRA Stolemenl below. 510(k) Number (if known) K190524 K l'1 o '> 2-t, Device Name MRopcn0.5T Indications for Usa (Describe) MRo… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242258 | MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) | 2024 | 0 |
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?
- The line of descent spans 28 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 14 of the 59 ancestors have a recall of any class.
- Of its descendants, K242258 (Asg Superconductors S.P.A., 2024) has gone furthest, with 0 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. 2019, 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?
MRopen EVO is a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging. MRopen EVO tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the body. The examinations may be performed both in weight free (supine or seated position) and weight bearing position. The images produced reflect the spatial distribution of protons (hydrogen…
Read the full statement (113 words)
MRopen EVO is a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging. MRopen EVO tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the body. The examinations may be performed both in weight free (supine or seated position) and weight bearing position. The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (Tl), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193116 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193116: MRopen EVO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193116
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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