510(k) · Cleared
ClearedI-Genius (100019400)
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 Jul 31, 2026 as substantially equivalent to K260746 (Esaote, S.p.A., 2026) after a 100-day review. Its family tree reaches back 21 generations to 1991.
- Decided
- Jul 31, 2026
- Review
- 100 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 21 generations to K911667 (1991). 58 ancestors in all. No later device cites it as a predicate yet.
- Root · 21 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 17 generations between
- 3 generations backK161238 S-scanEsaote, S.p.A. · 2016
- 2 generations backK161973 G-scan Brio, S-scanEsaote, S.p.A. · 2016
- 1 generation backK260746 S-scan Open (100001800)Esaote, S.p.A. · 2026
- This deviceK261331 I-Genius (100019400)Esaote, S.p.A. · 2026
Show all 21 generations
- Root · 21 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 20 generations backK963262 Artoscan MBiosound, Inc. · 1997
- 19 generations backK981358 Artoscan SBiosound Esaote, Inc. · 1998
- 18 generations backK990968 E-SCANBiosound Esaote, Inc. · 1999
- 17 generations backK020164 E-Scan XQBiosound Esaote, Inc. · 2002
- 16 generations backK032121 Modification to E-Scan XQEsaote, S.p.A. · 2003
- 15 generations backK042236 G-SCANEsaote, S.p.A. · 2004
- 14 generations backK060956 G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006
- 13 generations backK061429 Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006
- 12 generations backK080968 S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan…Esaote, S.p.A. · 2008
- 11 generations backK092469 O-Scan MR SystemEsaote, S.p.A. · 2009
- 10 generations backK110238 G-SCANEsaote, S.p.A. · 2011
- 9 generations backK111803 G-SCANEsaote, S.p.A. · 2011
- 8 generations backK122006 G-Scan BrioEsaote, S.p.A. · 2012
- 7 generations backK133490 G-Scan BrioEsaote, S.p.A. · 2013
- 6 generations backK142421 G-scan BrioEsaote, S.p.A. · 2015 · Recalled
- 5 generations backK151668 S-scanEsaote, S.p.A. · 2015
- 4 generations backK153039 MRI Dynamic Analysis PlusEsaote, S.p.A. · 2016
- 3 generations backK161238 S-scanEsaote, S.p.A. · 2016
- 2 generations backK161973 G-scan Brio, S-scanEsaote, S.p.A. · 2016
- 1 generation backK260746 S-scan Open (100001800)Esaote, S.p.A. · 2026
- This deviceK261331 I-Genius (100019400)Esaote, S.p.A. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K911667 | Hitachi MRP-7000 Magnetic Rosonance Device | Hitachi Medical Systems America, Inc. | 1991 | 2 |
| −20 | K963262 | Artoscan M | Biosound, Inc. | 1997 | — |
| −19 | K981358 | Artoscan S | Biosound Esaote, Inc. | 1998 | — |
| −18 | K990968 | E-SCAN | Biosound Esaote, Inc. | 1999 | — |
| −17 | K020164 | E-Scan XQ | Biosound Esaote, Inc. | 2002 | — |
| −16 | K032121 | Modification to E-Scan XQ | Esaote, S.p.A. | 2003 | — |
| −15 | K042236 | G-SCAN | Esaote, S.p.A. | 2004 | — |
| −14 | K060956 | G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan… | Esaote, S.p.A. | 2006 | — |
| −13 | K061429 | Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan Opera | Esaote, S.p.A. | 2006 | — |
| −12 | K080968 | S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan Opera | Esaote, S.p.A. | 2008 | — |
| −11 | K092469 | O-Scan MR System | Esaote, S.p.A. | 2009 | — |
| −10 | K110238 | G-SCAN | Esaote, S.p.A. | 2011 | — |
| −9 | K111803 | G-SCAN | Esaote, S.p.A. | 2011 | — |
| −8 | K122006 | G-Scan Brio | Esaote, S.p.A. | 2012 | — |
| −7 | K133490 | G-Scan Brio | Esaote, S.p.A. | 2013 | — |
| −6 | K142421 | G-scan Brio | Esaote, S.p.A. | 2015 | 1 |
| −5 | K151668 | S-scan | Esaote, S.p.A. | 2015 | — |
| −4 | K153039 | MRI Dynamic Analysis Plus | Esaote, S.p.A. | 2016 | — |
| −3 | K161238 | S-scan | Esaote, S.p.A. | 2016 | — |
| −2 | K161973 | G-scan Brio, S-scan | Esaote, S.p.A. | 2016 | — |
| −1 | K260746 | S-scan Open (100001800) | Esaote, S.p.A. | 2026 | — |
| 0 (this device) | K261331 | I-Genius (100019400) | 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 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K260746 | S-scan Open (100001800)Summary page 5…892.1000 Product Code(s) LNH | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K260746 S-scan Open LNH Device Description Summary 21 CFR 807.92(a)(4) I-Genius is a Magnetic Resonance (MR) system that produces cross-… | 2026 |
| † | K053309 | Altaire Interventional MR Package | 2006 |
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 1.2 years on median.
- 10 of the 58 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 the head. Target district: skull and brain.
The I-Genius device is intended to be used intraoperatively in a shielded operating room.
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/K261331 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261331: I-Genius (100019400).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261331
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026