510(k) · Cleared
ClearedMRJ Extended
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 Mar 10, 2008 as substantially equivalent to K033507 (Paramed S.R.L., 2004) and 1 other predicate after a 56-day review. Its family tree reaches back 9 generations to 1991. 8 later devices descend from it.
- Decided
- Mar 10, 2008
- Review
- 56 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K911667 (1991). 36 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 5 generations between
- 3 generations backK042236 G-SCANEsaote, S.p.A. · 2004
- 2 generations backK060956 G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006
- 1 generation backK063207 S-Scan Mri SystemEsaote, S.p.A. · 2006
- This deviceK080098 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 · 2 generations on · 4 of its ownK122034 MRJ 3300Paramed S.R.L. · 2012
- Descendant · 2 generations on · 3 of its ownK151466 MrOpenParamed S.R.L. · 2015
- Descendant · 3 generations on · 2 of its ownK190524 MRopen 0.5 TAsg Superconductors S.P.A. · 2019
Show all 9 generations
- Root · 9 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 8 generations backK963262 Artoscan MBiosound, Inc. · 1997
- 7 generations backK981358 Artoscan SBiosound Esaote, Inc. · 1998
- 6 generations backK990968 E-SCANBiosound Esaote, Inc. · 1999
- 5 generations backK020164 E-Scan XQBiosound Esaote, Inc. · 2002
- 4 generations backK032121 Modification to E-Scan XQEsaote, S.p.A. · 2003
- 3 generations backK042236 G-SCANEsaote, S.p.A. · 2004
- 2 generations backK060956 G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006
- 1 generation backK063207 S-Scan Mri SystemEsaote, S.p.A. · 2006
- This deviceK080098 MRJ ExtendedParamed S.R.L. · 2008
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- 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 · 2 generations on4descendants
- K151466MrOpenParamed S.R.L. · 2015 · 2 generations on3descendants
- K190524MRopen 0.5 TAsg Superconductors S.P.A. · 2019 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K911667 | Hitachi MRP-7000 Magnetic Rosonance Device | Hitachi Medical Systems America, Inc. | 1991 | 2 |
| −8 | K963262 | Artoscan M | Biosound, Inc. | 1997 | — |
| −7 | K981358 | Artoscan S | Biosound Esaote, Inc. | 1998 | — |
| −6 | K990968 | E-SCAN | Biosound Esaote, Inc. | 1999 | — |
| −5 | K020164 | E-Scan XQ | Biosound Esaote, Inc. | 2002 | — |
| −4 | K032121 | Modification to E-Scan XQ | Esaote, S.p.A. | 2003 | — |
| −3 | K042236 | G-SCAN | Esaote, S.p.A. | 2004 | — |
| −2 | K060956 | G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan… | Esaote, S.p.A. | 2006 | — |
| −1 | K063207 | S-Scan Mri System | Esaote, S.p.A. | 2006 | — |
| 0 (this device) | 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 | — |
| +2 | K122034 | MRJ 3300 | Paramed S.R.L. | 2012 | — |
| +2 | K151466 | MrOpen | Paramed S.R.L. | 2015 | — |
| +3 | K190524 | MRopen 0.5 T | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 2 | 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? (2)
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 2…lass of device: 21 CFR 892.1000, class Il Classification Number: 9OLNH 807.92(a)(3) Predicate Devices Paramed MrJ K033507 for all items excluded the L-spine coils/district of examination for which the Esaote S-Scan K063207 is addressed 807.9… | 2004 |
| * | K063207 | S-Scan Mri SystemSummary page 2…2 === 807.92(a)(3) Predicate Devices Paramed MrJ K033507 for all items excluded the L-spine coils/district of examination for which the Esaote S-Scan K063207 is addressed 807.92(a)(5) Device Intended Use(s) The MrJExtended intended use is the one of the predicate MrJ device (include… | 2006 |
What descends from it? (8)
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 17 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 7 of the 36 ancestors have a recall of any class.
- Of its descendants, K100164 (Paramed S.R.L., 2010) has gone furthest, with 7 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. 2008, 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 intended use of Paramed's MRJ Extended product is for diagnostic nuclear magnetic resonance imaging of hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, forearm, Temporo Mandibular Joint (TMJ), C- spine and L-Spine with limitation to joint pathologies (no tumors, no angiogripby), The device produces transverse, sagittal, coronal and oblique crass-sectional images, displaying the internal structure of the limbs and joint being…
Read the full statement (115 words)
The intended use of Paramed's MRJ Extended product is for diagnostic nuclear magnetic resonance imaging of hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, forearm, Temporo Mandibular Joint (TMJ), C- spine and L-Spine with limitation to joint pathologies (no tumors, no angiogripby), The device produces transverse, sagittal, coronal and oblique crass-sectional images, displaying the internal structure of the limbs and joint being imaged. eThe produced correspond to the spatial distribution of protons (hydrogen nuclei)that checkthe magnetic resonance properties and depen~d upon the MR paramneters (spirflatioe relaxatien time (Ti), 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 summary.
https://510kreport.com/device/K080098 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080098: MRJ Extended.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080098
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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