510(k) · Cleared
ClearedMRJ
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 Jan 20, 2004 after a 76-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 9 later devices descend from it.
- Decided
- Jan 20, 2004
- Review
- 76 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 5 citing it directly.
- This deviceK033507 MRJParamed S.R.L. · 2004
- Descendant · cites it directly · 8 of its ownK080098 MRJ ExtendedParamed S.R.L. · 2008
- Descendant · cites it directly · 7 of its ownK100164 MR Inspire with Extended KitParamed S.R.L. · 2010
- Descendant · cites it directly · 6 of its ownK121249 Multiarray KitParamed S.R.L. · 2012
- Descendant · cites it directly · 4 of its ownK122034 MRJ 3300Paramed S.R.L. · 2012
- Descendant · 2 generations on · 3 of its ownK151466 MrOpenParamed S.R.L. · 2015
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K080098MRJ ExtendedParamed S.R.L. · 2008 · cites it directly8descendants
- K100164MR Inspire with Extended KitParamed S.R.L. · 2010 · cites it directly7descendants
- K121249Multiarray KitParamed S.R.L. · 2012 · cites it directly6descendants
- K122034MRJ 3300Paramed S.R.L. · 2012 · cites it directly4descendants
- K151466MrOpenParamed S.R.L. · 2015 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033507 | MRJ | Paramed S.R.L. | 2004 | — |
| +1 | K080098 | MRJ Extended | Paramed S.R.L. | 2008 | — |
| +1 | K100164 | MR Inspire with Extended Kit | Paramed S.R.L. | 2010 | — |
| +1 | K121249 | Multiarray Kit | Paramed S.R.L. | 2012 | — |
| +1 | K122034 | MRJ 3300 | Paramed S.R.L. | 2012 | — |
| +2 | K151466 | MrOpen | Paramed S.R.L. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2015 | 1 | 0 |
| 2019 | 3 | 0 |
| 2024 | 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.
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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (9)
5 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, K080098 (Paramed S.R.L., 2008) has gone furthest, with 8 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 intended use of Paramed's MRJ product is for diagnostic MRI imaging of the hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, forearm, TMJ and cervical spine with limitation to joint pathologies - no tumors, no angiography. The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. The images produced correspond to the spatial…
Read the full statement (115 words)
The intended use of Paramed's MRJ product is for diagnostic MRI imaging of the hip,
knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, forearm, TMJ and
cervical spine with limitation to joint pathologies - no tumors, no angiography. The
device produces transverse, sagittal, coronal and oblique cross-sectional images,
displaying the internal structure of the limbs and joints being imaged. The images
produced correspond to the spatial distribution of protons (hydrogen nuclei) that check
the magnetic resonance properties and depend on the MR parameters (spin-lattice
relaxation time - T1, spin-spin relaxation time - T2, nuclei density, flow velocity and
chemical shift). If interpreted by a medical expert, these images can provide
diagnostically useful information.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K033507 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033507: MRJ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033507
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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