510(k) · Cleared
ClearedMRJ 3300
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 Dec 6, 2012 as substantially equivalent to K033507 (Paramed S.R.L., 2004) and 3 other predicates after a 148-day review. Its family tree reaches back 12 generations to 1991. 4 later devices descend from it.
- Decided
- Dec 6, 2012
- Review
- 148 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K911667 (1991). 41 ancestors in all. 4 later devices descend from it, 2 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 deviceK122034 MRJ 3300Paramed S.R.L. · 2012
- 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
- Descendant · cites it directly · 0 of its ownK192690 Upgrade Kit MR GUI PRO, MrJ 3300 PlusAsg Superconductors S.P.A. · 2019
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 deviceK122034 MRJ 3300Paramed S.R.L. · 2012
Most influential descendants
Showing 4 of 4 · See all- K190524MRopen 0.5 TAsg Superconductors S.P.A. · 2019 · cites it directly2descendants
- K193116MRopen EVOAsg Superconductors S.P.A. · 2019 · 2 generations on1descendant
- K242258MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)Asg Superconductors S.P.A. · 2024 · 3 generations on0descendants
- K192690Upgrade Kit MR GUI PRO, MrJ 3300 PlusAsg Superconductors S.P.A. · 2019 · cites it directly0descendants
View 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) | K122034 | MRJ 3300 | Paramed S.R.L. | 2012 | — |
| +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 | — |
| +1 | K192690 | Upgrade Kit MR GUI PRO, MrJ 3300 Plus | Asg Superconductors S.P.A. | 2019 | — |
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 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2004 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K033507 | MRJSummary page 1…umber: 9OLNH 807.92(a)(3) Predicate Devices Pararned . ..: ... i 1033507 Paramed MrJ, Inspire K(100164 Pararned MrOpenO05T… | 2004 |
| * | K100164 | MR Inspire with Extended KitSummary page 3…is substantially equivalent to: * Paramned Mr Inspire K(033507 for intended use; architecture, software. and positioning LED system. " Paramed Mr Inspire K100164 for intended use, covers' materials, and Touch panel positioning system. * Paramed Mropen065T k1oi295 for the FLAIR s… | 2010 |
| * | K101295 | MropenSummary page 6…District Decision with reference to with Mr3300 MrOpen 05T NixOpen 05T ____ ___ ___ ___ K101295 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ FLAIR TI FLAIR T… | 2010 |
| * | K121249 | Multiarray KitSummary page 1…1101295 K. Pararned Performance Pacage K121249 Section A 10 *… | 2012 |
What descends from it? (4)
2 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?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 7 of the 41 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.
- 4 other devices also cite its predicate K033507.
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. 2012, 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 MrJ 3300 is indicated for use as a diagnostic imaging device that produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the following joints: hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, forearm, Tempomo Mandibular Joint (TMJ), C-spine, L-Spine with limitation to joint pathologies (no tumors, no angiography). The images produced reflect the spatial distribution of…
Read the full statement (115 words)
The MrJ 3300 is indicated for use as a diagnostic imaging device that produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the following joints: hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, forearm, Tempomo Mandibular Joint (TMJ), C-spine, L-Spine with limitation to joint pathologies (no tumors, no angiography).
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 (I), 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/K122034 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122034: MRJ 3300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122034
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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