510(k) · Cleared
ClearedMrOpen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paramed S.R.L. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Oct 15, 2015 as substantially equivalent to K101295 (Paramed S.R.L., 2010) and 3 other predicates after a 136-day review. Its family tree reaches back 12 generations to 1991. 3 later devices descend from it.
- Decided
- Oct 15, 2015
- Review
- 136 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K911667 (1991). 45 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 8 generations between
- 3 generations backK080098 MRJ ExtendedParamed S.R.L. · 2008
- 2 generations backK100164 MR Inspire with Extended KitParamed S.R.L. · 2010
- 1 generation backK121249 Multiarray KitParamed S.R.L. · 2012
- This deviceK151466 MrOpenParamed S.R.L. · 2015
- Descendant · cites it directly · 2 of its ownK190524 MRopen 0.5 TAsg Superconductors S.P.A. · 2019
- Descendant · 2 generations on · 1 of its ownK193116 MRopen EVOAsg Superconductors S.P.A. · 2019
- Descendant · 3 generations on · 0 of its ownK242258 MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)Asg Superconductors S.P.A. · 2024
Show all 12 generations
- Root · 12 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 11 generations backK963262 Artoscan MBiosound, Inc. · 1997
- 10 generations backK981358 Artoscan SBiosound Esaote, Inc. · 1998
- 9 generations backK990968 E-SCANBiosound Esaote, Inc. · 1999
- 8 generations backK020164 E-Scan XQBiosound Esaote, Inc. · 2002
- 7 generations backK032121 Modification to E-Scan XQEsaote, S.p.A. · 2003
- 6 generations backK042236 G-SCANEsaote, S.p.A. · 2004
- 5 generations backK060956 G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006
- 4 generations backK063207 S-Scan Mri SystemEsaote, S.p.A. · 2006
- 3 generations backK080098 MRJ ExtendedParamed S.R.L. · 2008
- 2 generations backK100164 MR Inspire with Extended KitParamed S.R.L. · 2010
- 1 generation backK121249 Multiarray KitParamed S.R.L. · 2012
- This deviceK151466 MrOpenParamed S.R.L. · 2015
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K911667 | Hitachi MRP-7000 Magnetic Rosonance Device | Hitachi Medical Systems America, Inc. | 1991 | 2 |
| −11 | K963262 | Artoscan M | Biosound, Inc. | 1997 | — |
| −10 | K981358 | Artoscan S | Biosound Esaote, Inc. | 1998 | — |
| −9 | K990968 | E-SCAN | Biosound Esaote, Inc. | 1999 | — |
| −8 | K020164 | E-Scan XQ | Biosound Esaote, Inc. | 2002 | — |
| −7 | K032121 | Modification to E-Scan XQ | Esaote, S.p.A. | 2003 | — |
| −6 | K042236 | G-SCAN | Esaote, S.p.A. | 2004 | — |
| −5 | K060956 | G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan… | Esaote, S.p.A. | 2006 | — |
| −4 | K063207 | S-Scan Mri System | Esaote, S.p.A. | 2006 | — |
| −3 | K080098 | MRJ Extended | Paramed S.R.L. | 2008 | — |
| −2 | K100164 | MR Inspire with Extended Kit | Paramed S.R.L. | 2010 | — |
| −1 | K121249 | Multiarray Kit | Paramed S.R.L. | 2012 | — |
| 0 (this device) | K151466 | MrOpen | Paramed S.R.L. | 2015 | — |
| +1 | K190524 | MRopen 0.5 T | Asg Superconductors S.P.A. | 2019 | — |
| +2 | K193116 | MRopen EVO | Asg Superconductors S.P.A. | 2019 | — |
| +3 | 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 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2004 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K101295 | MropenSummary page 5…23 f437 807.92(a)(3) &n identification of the legally marketed device to which the submitter claims equivalence. PRIMARY PREDICATE: Paramed MrOpen 0.5T K101295 SECONDARY PREDICATE (FOR ANGIOGRAPHY APPLICATION) Toshiba OPART K990260 SECONDARY PREDICATE (FOR SPINE COIL USE) Paramed Spine C… | 2010 |
| * | K990260 | OPARTSummary page 5…rketed device to which the submitter claims equivalence. PRIMARY PREDICATE: Paramed MrOpen 0.5T K101295 SECONDARY PREDICATE (FOR ANGIOGRAPHY APPLICATION) Toshiba OPART K990260 SECONDARY PREDICATE (FOR SPINE COIL USE) Paramed Spine COIL K123708 SECONDARY PREDICATE (FOR MATERIALS) Paramed Performance pac… | 1999 |
| * | K123708 | Spine CoilSummary page 5…DICATE: Paramed MrOpen 0.5T K101295 SECONDARY PREDICATE (FOR ANGIOGRAPHY APPLICATION) Toshiba OPART K990260 SECONDARY PREDICATE (FOR SPINE COIL USE) Paramed Spine COIL K123708 SECONDARY PREDICATE (FOR MATERIALS) Paramed Performance package K121249 807.92(a)(4) o description of the device that is the su… | 2013 |
| * | K121249 | Multiarray KitSummary page 5…APPLICATION) Toshiba OPART K990260 SECONDARY PREDICATE (FOR SPINE COIL USE) Paramed Spine COIL K123708 SECONDARY PREDICATE (FOR MATERIALS) Paramed Performance package K121249 807.92(a)(4) o description of the device that is the subject of the premarket notification submission, such as might be found in… | 2012 |
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 |
|---|---|---|---|
| K190524 | MRopen 0.5 T | 2019 | 2 |
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 24 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 7 of the 45 ancestors have a recall of any class.
- Of its descendants, K190524 (Asg Superconductors S.P.A., 2019) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K101295.
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. 2015, 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 03 is indicated for use as a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging. MrOpen 05 tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the intemal structure of the body. The examinations may be performed botl in weight free (supine or scated position) and weight bearing position. The images produced reflect the spatial distribution of…
Read the full statement (117 words)
MrOpen 03 is indicated for use as a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging. MrOpen 05 tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the intemal structure of the body. The examinations may be performed botl in weight free (supine or scated position) and weight bearing position.
The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance.
The MR paramctcers that determine image appearance are proton deusily, spin-lattice relaxation time (T1), 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151466 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151466: MrOpen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151466
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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