510(k) · Cleared
ClearedS-scan Open (100001800)
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 27, 2026 as substantially equivalent to K161973 (Esaote, S.p.A., 2016) after a 21-day review. Its family tree reaches back 20 generations to 1991. 1 later device descends from it.
- Decided
- Mar 27, 2026
- Review
- 21 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 20 generations to K911667 (1991). 57 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 20 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 16 generations between
- 3 generations backK153039 MRI Dynamic Analysis PlusEsaote, S.p.A. · 2016
- 2 generations backK161238 S-scanEsaote, S.p.A. · 2016
- 1 generation backK161973 G-scan Brio, S-scanEsaote, S.p.A. · 2016
- This deviceK260746 S-scan Open (100001800)Esaote, S.p.A. · 2026
- Descendant · cites it directly · 0 of its ownK261331 I-Genius (100019400)Esaote, S.p.A. · 2026
Show all 20 generations
- Root · 20 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 19 generations backK963262 Artoscan MBiosound, Inc. · 1997
- 18 generations backK981358 Artoscan SBiosound Esaote, Inc. · 1998
- 17 generations backK990968 E-SCANBiosound Esaote, Inc. · 1999
- 16 generations backK020164 E-Scan XQBiosound Esaote, Inc. · 2002
- 15 generations backK032121 Modification to E-Scan XQEsaote, S.p.A. · 2003
- 14 generations backK042236 G-SCANEsaote, S.p.A. · 2004
- 13 generations backK060956 G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006
- 12 generations backK061429 Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006
- 11 generations backK080968 S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan…Esaote, S.p.A. · 2008
- 10 generations backK092469 O-Scan MR SystemEsaote, S.p.A. · 2009
- 9 generations backK110238 G-SCANEsaote, S.p.A. · 2011
- 8 generations backK111803 G-SCANEsaote, S.p.A. · 2011
- 7 generations backK122006 G-Scan BrioEsaote, S.p.A. · 2012
- 6 generations backK133490 G-Scan BrioEsaote, S.p.A. · 2013
- 5 generations backK142421 G-scan BrioEsaote, S.p.A. · 2015 · Recalled
- 4 generations backK151668 S-scanEsaote, S.p.A. · 2015
- 3 generations backK153039 MRI Dynamic Analysis PlusEsaote, S.p.A. · 2016
- 2 generations backK161238 S-scanEsaote, S.p.A. · 2016
- 1 generation backK161973 G-scan Brio, S-scanEsaote, S.p.A. · 2016
- This deviceK260746 S-scan Open (100001800)Esaote, S.p.A. · 2026
Most influential descendants
Showing 1 of 1 · See all- K261331I-Genius (100019400)Esaote, S.p.A. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K911667 | Hitachi MRP-7000 Magnetic Rosonance Device | Hitachi Medical Systems America, Inc. | 1991 | 2 |
| −19 | K963262 | Artoscan M | Biosound, Inc. | 1997 | — |
| −18 | K981358 | Artoscan S | Biosound Esaote, Inc. | 1998 | — |
| −17 | K990968 | E-SCAN | Biosound Esaote, Inc. | 1999 | — |
| −16 | K020164 | E-Scan XQ | Biosound Esaote, Inc. | 2002 | — |
| −15 | K032121 | Modification to E-Scan XQ | Esaote, S.p.A. | 2003 | — |
| −14 | K042236 | G-SCAN | Esaote, S.p.A. | 2004 | — |
| −13 | K060956 | G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan… | Esaote, S.p.A. | 2006 | — |
| −12 | K061429 | Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan Opera | Esaote, S.p.A. | 2006 | — |
| −11 | K080968 | S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan Opera | Esaote, S.p.A. | 2008 | — |
| −10 | K092469 | O-Scan MR System | Esaote, S.p.A. | 2009 | — |
| −9 | K110238 | G-SCAN | Esaote, S.p.A. | 2011 | — |
| −8 | K111803 | G-SCAN | Esaote, S.p.A. | 2011 | — |
| −7 | K122006 | G-Scan Brio | Esaote, S.p.A. | 2012 | — |
| −6 | K133490 | G-Scan Brio | Esaote, S.p.A. | 2013 | — |
| −5 | K142421 | G-scan Brio | Esaote, S.p.A. | 2015 | 1 |
| −4 | K151668 | S-scan | Esaote, S.p.A. | 2015 | — |
| −3 | K153039 | MRI Dynamic Analysis Plus | Esaote, S.p.A. | 2016 | — |
| −2 | K161238 | S-scan | Esaote, S.p.A. | 2016 | — |
| −1 | K161973 | G-scan Brio, S-scan | Esaote, S.p.A. | 2016 | — |
| 0 (this device) | K260746 | S-scan Open (100001800) | Esaote, S.p.A. | 2026 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K161973 | G-scan Brio, S-scanSummary page 5…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K161973 S-scan LNH Device De… | 2016 |
| † | K180592 | G-scan Brio | 2018 |
| † | K251901 | Magnifico Open (100009900) | 2026 |
| † | K230854 | SwiftMR | 2023 |
| † | K142421 | G-scan Brio | 2015 |
| † | K080968 | S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan Opera | 2008 |
| † | K042236 | G-SCAN | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261331 | I-Genius (100019400) | 2026 | 0 |
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.
- 10 of the 57 ancestors have a recall of any class.
- Of its descendants, K261331 (Esaote, S.p.A., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K161973.
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 upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh, hip, imaging the temporomandibular joint, imaging the cervical, the thoracic, the lumbar and the sacral sections as portions of the spinal column, and imaging the head.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260746 · printed Nov 5, 2026
Cite this page
510(k) Report. “K260746: S-scan Open (100001800).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K260746
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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