510(k) · Cleared
ClearedMultiarray Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paramed S.R.L. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Jun 12, 2012 as substantially equivalent to K033507 (Paramed S.R.L., 2004) and 2 other predicates after a 48-day review. Its family tree reaches back 11 generations to 1991. 6 later devices descend from it.
- Decided
- Jun 12, 2012
- Review
- 48 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K911667 (1991). 38 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 7 generations between
- 3 generations backK063207 S-Scan Mri SystemEsaote, S.p.A. · 2006
- 2 generations backK080098 MRJ ExtendedParamed S.R.L. · 2008
- 1 generation backK100164 MR Inspire with Extended KitParamed S.R.L. · 2010
- This deviceK121249 Multiarray KitParamed S.R.L. · 2012
- 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
- Descendant · 4 generations on · 0 of its ownK242258 MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)Asg Superconductors S.P.A. · 2024
Show all 11 generations
- Root · 11 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 10 generations backK963262 Artoscan MBiosound, Inc. · 1997
- 9 generations backK981358 Artoscan SBiosound Esaote, Inc. · 1998
- 8 generations backK990968 E-SCANBiosound Esaote, Inc. · 1999
- 7 generations backK020164 E-Scan XQBiosound Esaote, Inc. · 2002
- 6 generations backK032121 Modification to E-Scan XQEsaote, S.p.A. · 2003
- 5 generations backK042236 G-SCANEsaote, S.p.A. · 2004
- 4 generations backK060956 G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006
- 3 generations backK063207 S-Scan Mri SystemEsaote, S.p.A. · 2006
- 2 generations backK080098 MRJ ExtendedParamed S.R.L. · 2008
- 1 generation backK100164 MR Inspire with Extended KitParamed S.R.L. · 2010
- This deviceK121249 Multiarray KitParamed S.R.L. · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- 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
- K242258MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)Asg Superconductors S.P.A. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K911667 | Hitachi MRP-7000 Magnetic Rosonance Device | Hitachi Medical Systems America, Inc. | 1991 | 2 |
| −10 | K963262 | Artoscan M | Biosound, Inc. | 1997 | — |
| −9 | K981358 | Artoscan S | Biosound Esaote, Inc. | 1998 | — |
| −8 | K990968 | E-SCAN | Biosound Esaote, Inc. | 1999 | — |
| −7 | K020164 | E-Scan XQ | Biosound Esaote, Inc. | 2002 | — |
| −6 | K032121 | Modification to E-Scan XQ | Esaote, S.p.A. | 2003 | — |
| −5 | K042236 | G-SCAN | Esaote, S.p.A. | 2004 | — |
| −4 | K060956 | G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan… | Esaote, S.p.A. | 2006 | — |
| −3 | K063207 | S-Scan Mri System | Esaote, S.p.A. | 2006 | — |
| −2 | K080098 | MRJ Extended | Paramed S.R.L. | 2008 | — |
| −1 | K100164 | MR Inspire with Extended Kit | Paramed S.R.L. | 2010 | — |
| 0 (this device) | K121249 | Multiarray Kit | Paramed S.R.L. | 2012 | — |
| +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 | — |
| +4 | 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 |
| 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 |
|---|---|---|
| 2012 | 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 MOS? 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 MOS device
- #1 K253738 3.0T Air 32CH Hnascore 15.2 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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…AvnRCOU MEDICAL SYSTEMS 807.92(a)(3) Predicate Devices Paramed NMrS K033507 Pararned IM Extended K080098 Paramed MRS Inspire… | 2004 |
| * | K080098 | MRJ ExtendedSummary page 2…a)(3) Predicate Devices Paramed NMrS K033507 Pararned IM Extended K080098 Paramed MRS Inspire K100164 807, 92(g) (4) Description of the device th… | 2008 |
| * | K100164 | MR Inspire with Extended KitSummary page 2…K033507 Pararned IM Extended K080098 Paramed MRS Inspire K100164 807, 92(g) (4) Description of the device that is the subject of the premarket notification sub mission Th… | 2010 |
What descends from it? (6)
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 38 ancestors have a recall of any class.
- Of its descendants, K122034 (Paramed S.R.L., 2012) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K033507.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MOS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MOS
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOS
13in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOS
2in 2025
MAUDE reports naming product code MOS, 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 | 16 | 19 | 0 | 4 |
| 2008 | 19 | 33 | 2 | 2 |
| 2009 | 10 | 43 | 0 | 5 |
| 2010 | 16 | 78 | 1 | 13 |
| 2011 | 25 | 57 | 0 | 7 |
| 2012 | 15 | 49 | 1 | 12 |
| 2013 | 7 | 87 | 0 | 10 |
| 2014 | 12 | 60 | 0 | 4 |
| 2015 | 6 | 58 | 2 | 5 |
| 2016 | 11 | 42 | 0 | 7 |
| 2017 | 9 | 63 | 0 | 9 |
| 2018 | 10 | 30 | 0 | 7 |
| 2019 | 3 | 178 | 8 | 8 |
| 2020 | 5 | 51 | 1 | 2 |
| 2021 | 4 | 41 | 0 | 3 |
| 2022 | 11 | 79 | 0 | 5 |
| 2023 | 10 | 59 | 0 | 4 |
| 2024 | 10 | 39 | 13 | 8 |
| 2025 | 3 | 59 | 0 | 2 |
| 2026 | 10 | 45 | 0 | — |
What is it indicated for?
The intended use of the Performance Package is to enable the permanent magnet based MRI systems designed by Paramed (MrJ and MrJ Inspire) to perfornn MR scan of the following districts: C-Spine one dedicated coil (code 0 1-2023), L-Spine two sizes of dedicated coils (codes 01-202 1 and 01-2022), all other joints using a linear single channel coil named ME_wrap (code 01-2024) which is not aimed to specific districts but can fit most joints (such as, for…
Read the full statement (190 words)
The intended use of the Performance Package is to enable the permanent magnet based MRI systems designed by Paramed (MrJ and MrJ Inspire) to perfornn MR scan of the following districts: C-Spine one dedicated coil (code 0 1-2023), L-Spine two sizes of dedicated coils (codes 01-202 1 and 01-2022), all other joints using a linear single channel coil named ME_wrap (code 01-2024) which is not aimed to specific districts but can fit most joints (such as, for instance, knee, foot, ankle, elbow, wrist, hand ... ). The Performance Package inherits the same limitations of the System to which it is applied which is: only joint pathologies (no tumor, no angiography). The Performance Package enables the MRI System to which it is applied to acquire images of the districts being diagnosed in transverse, sagittal, coronal and oblique cross-sectional directions. The images which are produced correspond to spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon MR parameters (spin-lattice relaxation time (TI), spin-spin relaxation te ff2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically usefuil information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121249: Multiarray Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121249
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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