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 Jul 28, 2010 as substantially equivalent to K073362 (Paramed S.R.L., 2008) after a 79-day review. Its family tree reaches back 1 generation to 2008. 7 later devices descend from it.
- Decided
- Jul 28, 2010
- Review
- 79 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K073362 (2008). 7 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK073362 MropenParamed S.R.L. · 2008
- This deviceK101295 MropenParamed S.R.L. · 2010
- Descendant · cites it directly · 4 of its ownK123708 Spine CoilUsa Paramed Medical Systems, Inc. · 2013
- Descendant · cites it directly · 4 of its ownK122034 MRJ 3300Paramed S.R.L. · 2012
- Descendant · cites it directly · 3 of its ownK151466 MrOpenParamed S.R.L. · 2015
- Descendant · 2 generations on · 2 of its ownK190524 MRopen 0.5 TAsg Superconductors S.P.A. · 2019
- Descendant · 3 generations on · 1 of its ownK193116 MRopen EVOAsg Superconductors S.P.A. · 2019
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K123708Spine CoilUsa Paramed Medical Systems, Inc. · 2013 · cites it directly4descendants
- K122034MRJ 3300Paramed S.R.L. · 2012 · cites it directly4descendants
- K151466MrOpenParamed S.R.L. · 2015 · cites it directly3descendants
- K190524MRopen 0.5 TAsg Superconductors S.P.A. · 2019 · 2 generations on2descendants
- K193116MRopen EVOAsg Superconductors S.P.A. · 2019 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K073362 | Mropen | Paramed S.R.L. | 2008 | — |
| 0 (this device) | K101295 | Mropen | Paramed S.R.L. | 2010 | — |
| +1 | K123708 | Spine Coil | Usa Paramed Medical Systems, Inc. | 2013 | — |
| +1 | K122034 | MRJ 3300 | Paramed S.R.L. | 2012 | — |
| +1 | K151466 | MrOpen | Paramed S.R.L. | 2015 | — |
| +2 | K190524 | MRopen 0.5 T | Asg Superconductors S.P.A. | 2019 | — |
| +3 | K193116 | MRopen EVO | Asg Superconductors S.P.A. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 3 | 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? (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 |
|---|---|---|---|
| * | K073362 | MropenSummary page 2…lass of device: 21 CFR 892. 1000, class 11 Classification Number: 9OLNH 807.92(a)(3) Predicate Devices Paramed MrOpen K073362 807.92(a)(5) Device Intended Use(s) The intended use of Paramed's MrOpen 05 product is indicated for use as a diagnostic tota… | 2008 |
What descends from it? (7)
3 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?
- Its one ancestor has no recall.
- Of its descendants, K123708 (Usa Paramed Medical Systems, Inc., 2013) has gone furthest, with 4 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. 2010, 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 MR Open is indicated for use as a diagnostic total body imaging device with the following limitation: no angiography, no cardiac imaging, no breast imaging. MR Open tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the body. The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The MR parameters that determine image…
Read the full statement (103 words)
The MR Open is indicated for use as a diagnostic total body imaging device with the following limitation: no angiography, no cardiac imaging, no breast imaging.
MR Open tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the body.
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 (TI), 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/K101295 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101295: Mropen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101295
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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