510(k) · Cleared
ClearedMagnifico Open (100009900)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Esaote, S.p.A. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Mar 5, 2026 as substantially equivalent to K241133 (Esaote, S.p.A., 2024) after a 258-day review. Its family tree reaches back 22 generations to 1991.
- Decided
- Mar 5, 2026
- Review
- 258 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 22 generations to K911667 (1991). 80 ancestors in all. No later device cites it as a predicate yet.
- Root · 22 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 18 generations between
- 3 generations backK161973 G-scan Brio, S-scanEsaote, S.p.A. · 2016
- 2 generations backK212419 Magnifico Open, Magnifico MSKEsaote, S.p.A. · 2022
- 1 generation backK241133 Magnifico Open (100009900); Magnifico MSK ( 100009910)Esaote, S.p.A. · 2024
- This deviceK251901 Magnifico Open (100009900)Esaote, S.p.A. · 2026
Show all 22 generations
- Root · 22 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 21 generations backK963262 Artoscan MBiosound, Inc. · 1997
- 20 generations backK981358 Artoscan SBiosound Esaote, Inc. · 1998
- 19 generations backK990968 E-SCANBiosound Esaote, Inc. · 1999
- 18 generations backK020164 E-Scan XQBiosound Esaote, Inc. · 2002
- 17 generations backK032121 Modification to E-Scan XQEsaote, S.p.A. · 2003
- 16 generations backK042236 G-SCANEsaote, S.p.A. · 2004
- 15 generations backK060956 G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006
- 14 generations backK061429 Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006
- 13 generations backK080968 S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan…Esaote, S.p.A. · 2008
- 12 generations backK092469 O-Scan MR SystemEsaote, S.p.A. · 2009
- 11 generations backK110238 G-SCANEsaote, S.p.A. · 2011
- 10 generations backK111803 G-SCANEsaote, S.p.A. · 2011
- 9 generations backK122006 G-Scan BrioEsaote, S.p.A. · 2012
- 8 generations backK133490 G-Scan BrioEsaote, S.p.A. · 2013
- 7 generations backK142421 G-scan BrioEsaote, S.p.A. · 2015 · Recalled
- 6 generations backK151668 S-scanEsaote, S.p.A. · 2015
- 5 generations backK153039 MRI Dynamic Analysis PlusEsaote, S.p.A. · 2016
- 4 generations backK161238 S-scanEsaote, S.p.A. · 2016
- 3 generations backK161973 G-scan Brio, S-scanEsaote, S.p.A. · 2016
- 2 generations backK212419 Magnifico Open, Magnifico MSKEsaote, S.p.A. · 2022
- 1 generation backK241133 Magnifico Open (100009900); Magnifico MSK ( 100009910)Esaote, S.p.A. · 2024
- This deviceK251901 Magnifico Open (100009900)Esaote, S.p.A. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K911667 | Hitachi MRP-7000 Magnetic Rosonance Device | Hitachi Medical Systems America, Inc. | 1991 | 2 |
| −21 | K963262 | Artoscan M | Biosound, Inc. | 1997 | — |
| −20 | K981358 | Artoscan S | Biosound Esaote, Inc. | 1998 | — |
| −19 | K990968 | E-SCAN | Biosound Esaote, Inc. | 1999 | — |
| −18 | K020164 | E-Scan XQ | Biosound Esaote, Inc. | 2002 | — |
| −17 | K032121 | Modification to E-Scan XQ | Esaote, S.p.A. | 2003 | — |
| −16 | K042236 | G-SCAN | Esaote, S.p.A. | 2004 | — |
| −15 | K060956 | G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan… | Esaote, S.p.A. | 2006 | — |
| −14 | K061429 | Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan Opera | Esaote, S.p.A. | 2006 | — |
| −13 | K080968 | S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan Opera | Esaote, S.p.A. | 2008 | — |
| −12 | K092469 | O-Scan MR System | Esaote, S.p.A. | 2009 | — |
| −11 | K110238 | G-SCAN | Esaote, S.p.A. | 2011 | — |
| −10 | K111803 | G-SCAN | Esaote, S.p.A. | 2011 | — |
| −9 | K122006 | G-Scan Brio | Esaote, S.p.A. | 2012 | — |
| −8 | K133490 | G-Scan Brio | Esaote, S.p.A. | 2013 | — |
| −7 | K142421 | G-scan Brio | Esaote, S.p.A. | 2015 | 1 |
| −6 | K151668 | S-scan | Esaote, S.p.A. | 2015 | — |
| −5 | K153039 | MRI Dynamic Analysis Plus | Esaote, S.p.A. | 2016 | — |
| −4 | K161238 | S-scan | Esaote, S.p.A. | 2016 | — |
| −3 | K161973 | G-scan Brio, S-scan | Esaote, S.p.A. | 2016 | — |
| −2 | K212419 | Magnifico Open, Magnifico MSK | Esaote, S.p.A. | 2022 | — |
| −1 | K241133 | Magnifico Open (100009900); Magnifico MSK ( 100009910) | Esaote, S.p.A. | 2024 | — |
| 0 (this device) | K251901 | Magnifico Open (100009900) | Esaote, S.p.A. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 4 | 0 |
| 1994 | 4 | 0 |
| 1995 | 4 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 6 | 0 |
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 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.
What descends from it?
No later submission names this one as a predicate yet.
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 35 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 16 of the 80 ancestors have a recall of any class.
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. 2026, 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 general-purpose magnetic resonance imaging (MRI) device is designed to scan any targeted area of the body, to collect, display and analyse MR images and other real-time imaging procedures.
The indications for use are the following:
Imaging portions of calf, knee, ankle, foot, thigh, hand, wrist, forearm, elbow, arm, shoulder, hip, lumbar column, sacral column, cervical column, thoracic spine, pelvis, temporomandibular joint (included only for "Open" configuration), head (included only for "Open" configuration) and upper abdomen (included only for "Open" configuration under option).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K251901 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251901: Magnifico Open (100009900).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251901
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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