510(k) · Cleared
ClearedS-scan
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 8, 2016 as substantially equivalent to K153039 (Esaote, S.p.A., 2016) after a 67-day review. Its family tree reaches back 18 generations to 1991. 6 later devices descend from it.
- Decided
- Jul 8, 2016
- Review
- 67 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 18 generations to K911667 (1991). 55 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 18 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 14 generations between
- 3 generations backK142421 G-scan BrioEsaote, S.p.A. · 2015 · Recalled
- 2 generations backK151668 S-scanEsaote, S.p.A. · 2015
- 1 generation backK153039 MRI Dynamic Analysis PlusEsaote, S.p.A. · 2016
- This deviceK161238 S-scanEsaote, S.p.A. · 2016
- Descendant · cites it directly · 5 of its ownK161973 G-scan Brio, S-scanEsaote, S.p.A. · 2016
- Descendant · 2 generations on · 2 of its ownK212419 Magnifico Open, Magnifico MSKEsaote, S.p.A. · 2022
- Descendant · 2 generations on · 1 of its ownK260746 S-scan Open (100001800)Esaote, S.p.A. · 2026
- Descendant · 3 generations on · 1 of its ownK241133 Magnifico Open (100009900); Magnifico MSK ( 100009910)Esaote, S.p.A. · 2024
- Descendant · 3 generations on · 0 of its ownK261331 I-Genius (100019400)Esaote, S.p.A. · 2026
Show all 18 generations
- Root · 18 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 17 generations backK963262 Artoscan MBiosound, Inc. · 1997
- 16 generations backK981358 Artoscan SBiosound Esaote, Inc. · 1998
- 15 generations backK990968 E-SCANBiosound Esaote, Inc. · 1999
- 14 generations backK020164 E-Scan XQBiosound Esaote, Inc. · 2002
- 13 generations backK032121 Modification to E-Scan XQEsaote, S.p.A. · 2003
- 12 generations backK042236 G-SCANEsaote, S.p.A. · 2004
- 11 generations backK060956 G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006
- 10 generations backK061429 Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006
- 9 generations backK080968 S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan…Esaote, S.p.A. · 2008
- 8 generations backK092469 O-Scan MR SystemEsaote, S.p.A. · 2009
- 7 generations backK110238 G-SCANEsaote, S.p.A. · 2011
- 6 generations backK111803 G-SCANEsaote, S.p.A. · 2011
- 5 generations backK122006 G-Scan BrioEsaote, S.p.A. · 2012
- 4 generations backK133490 G-Scan BrioEsaote, S.p.A. · 2013
- 3 generations backK142421 G-scan BrioEsaote, S.p.A. · 2015 · Recalled
- 2 generations backK151668 S-scanEsaote, S.p.A. · 2015
- 1 generation backK153039 MRI Dynamic Analysis PlusEsaote, S.p.A. · 2016
- This deviceK161238 S-scanEsaote, S.p.A. · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K161973G-scan Brio, S-scanEsaote, S.p.A. · 2016 · cites it directly5descendants
- K212419Magnifico Open, Magnifico MSKEsaote, S.p.A. · 2022 · 2 generations on2descendants
- K260746S-scan Open (100001800)Esaote, S.p.A. · 2026 · 2 generations on1descendant
- K241133Magnifico Open (100009900); Magnifico MSK ( 100009910)Esaote, S.p.A. · 2024 · 3 generations on1descendant
- K261331I-Genius (100019400)Esaote, S.p.A. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K911667 | Hitachi MRP-7000 Magnetic Rosonance Device | Hitachi Medical Systems America, Inc. | 1991 | 2 |
| −17 | K963262 | Artoscan M | Biosound, Inc. | 1997 | — |
| −16 | K981358 | Artoscan S | Biosound Esaote, Inc. | 1998 | — |
| −15 | K990968 | E-SCAN | Biosound Esaote, Inc. | 1999 | — |
| −14 | K020164 | E-Scan XQ | Biosound Esaote, Inc. | 2002 | — |
| −13 | K032121 | Modification to E-Scan XQ | Esaote, S.p.A. | 2003 | — |
| −12 | K042236 | G-SCAN | Esaote, S.p.A. | 2004 | — |
| −11 | K060956 | G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan… | Esaote, S.p.A. | 2006 | — |
| −10 | K061429 | Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan Opera | Esaote, S.p.A. | 2006 | — |
| −9 | K080968 | S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan Opera | Esaote, S.p.A. | 2008 | — |
| −8 | K092469 | O-Scan MR System | Esaote, S.p.A. | 2009 | — |
| −7 | K110238 | G-SCAN | Esaote, S.p.A. | 2011 | — |
| −6 | K111803 | G-SCAN | Esaote, S.p.A. | 2011 | — |
| −5 | K122006 | G-Scan Brio | Esaote, S.p.A. | 2012 | — |
| −4 | K133490 | G-Scan Brio | Esaote, S.p.A. | 2013 | — |
| −3 | K142421 | G-scan Brio | Esaote, S.p.A. | 2015 | 1 |
| −2 | K151668 | S-scan | Esaote, S.p.A. | 2015 | — |
| −1 | K153039 | MRI Dynamic Analysis Plus | Esaote, S.p.A. | 2016 | — |
| 0 (this device) | K161238 | S-scan | Esaote, S.p.A. | 2016 | — |
| +1 | K161973 | G-scan Brio, S-scan | Esaote, S.p.A. | 2016 | — |
| +2 | K212419 | Magnifico Open, Magnifico MSK | Esaote, S.p.A. | 2022 | — |
| +2 | K260746 | S-scan Open (100001800) | Esaote, S.p.A. | 2026 | — |
| +3 | K241133 | Magnifico Open (100009900); Magnifico MSK ( 100009910) | Esaote, S.p.A. | 2024 | — |
| +3 | 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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K153039 | MRI Dynamic Analysis PlusSummary page 4…lass Product Manufacturer K number name code S-scan System, nuclear magnetic II LNH ESAOTE K153039 resonance imaging S.P.A 510(k) Submission S-scan Esaote, S.p.A.… | 2016 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161973 | G-scan Brio, S-scan | 2016 | 5 |
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 25 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 10 of the 55 ancestors have a recall of any class.
- Of its descendants, K161973 (Esaote, S.p.A., 2016) has gone furthest, with 5 descendants of its own.
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. 2016, 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?
S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal, coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for 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 and hip, imaging the temporomandibular joint and imaging the cervical, the thoracic and the…
Read the full statement (135 words)
S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal, coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for 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 and hip, imaging the temporomandibular joint and imaging the cervical, the thoracic and the lumbosacral sections as portions of the spinal column.
S-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spinlattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and “chemical shift”. When interpreted by a medical expert trained in use of MR equipment, the images can provide diagnostically useful information.
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/K161238 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161238: S-scan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161238
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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