510(k) · Cleared
ClearedS-Scan Mri System
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 Nov 9, 2006 as substantially equivalent to K042236 (Esaote, S.p.A., 2004) and 3 other predicates after a 17-day review. Its family tree reaches back 8 generations to 1991. 34 later devices descend from it.
- Decided
- Nov 9, 2006
- Review
- 17 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K911667 (1991). 34 ancestors in all. 34 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 7 generations backK963262 Artoscan MBiosound, Inc. · 1997
- 6 generations backK981358 Artoscan SBiosound Esaote, Inc. · 1998
- 5 generations backK990968 E-SCANBiosound Esaote, Inc. · 1999
- 4 generations backK020164 E-Scan XQBiosound Esaote, Inc. · 2002
- 3 generations backK032121 Modification to E-Scan XQEsaote, S.p.A. · 2003
- 2 generations backK042236 G-SCANEsaote, S.p.A. · 2004
- 1 generation backK060956 G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006
- This deviceK063207 S-Scan Mri SystemEsaote, S.p.A. · 2006
- Descendant · cites it directly · 24 of its ownK080968 S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan…Esaote, S.p.A. · 2008
- Descendant · 2 generations on · 18 of its ownK092469 O-Scan MR SystemEsaote, S.p.A. · 2009
- Descendant · 2 generations on · 15 of its ownK110238 G-SCANEsaote, S.p.A. · 2011
- Descendant · 3 generations on · 14 of its ownK111803 G-SCANEsaote, S.p.A. · 2011
- Descendant · 4 generations on · 11 of its ownK122006 G-Scan BrioEsaote, S.p.A. · 2012
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K080968S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan OperaEsaote, S.p.A. · 2008 · cites it directly24descendants
- K092469O-Scan MR SystemEsaote, S.p.A. · 2009 · 2 generations on18descendants
- K110238G-SCANEsaote, S.p.A. · 2011 · 2 generations on15descendants
- K111803G-SCANEsaote, S.p.A. · 2011 · 3 generations on14descendants
- K122006G-Scan BrioEsaote, S.p.A. · 2012 · 4 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K911667 | Hitachi MRP-7000 Magnetic Rosonance Device | Hitachi Medical Systems America, Inc. | 1991 | 2 |
| −7 | K963262 | Artoscan M | Biosound, Inc. | 1997 | — |
| −6 | K981358 | Artoscan S | Biosound Esaote, Inc. | 1998 | — |
| −5 | K990968 | E-SCAN | Biosound Esaote, Inc. | 1999 | — |
| −4 | K020164 | E-Scan XQ | Biosound Esaote, Inc. | 2002 | — |
| −3 | K032121 | Modification to E-Scan XQ | Esaote, S.p.A. | 2003 | — |
| −2 | K042236 | G-SCAN | Esaote, S.p.A. | 2004 | — |
| −1 | K060956 | G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan… | Esaote, S.p.A. | 2006 | — |
| 0 (this device) | K063207 | S-Scan Mri System | Esaote, S.p.A. | 2006 | — |
| +1 | K080968 | S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan Opera | Esaote, S.p.A. | 2008 | — |
| +2 | K092469 | O-Scan MR System | Esaote, S.p.A. | 2009 | — |
| +2 | K110238 | G-SCAN | Esaote, S.p.A. | 2011 | — |
| +3 | K111803 | G-SCAN | Esaote, S.p.A. | 2011 | — |
| +4 | K122006 | G-Scan Brio | Esaote, S.p.A. | 2012 | — |
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 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 6 | 0 |
| 2013 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2019 | 4 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K042236 | G-SCANSummary page 1…nance diagnostic device Classification Number: 9OLNH 807.92(a)(3) Predicate Device(s) Esaote G-scan K042236 Esaote E-scan Opera K060956 Siemens Magnetomn C! K043030 USA Instrumen… | 2004 |
| * | K060956 | G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Summary page 1…9OLNH 807.92(a)(3) Predicate Device(s) Esaote G-scan K042236 Esaote E-scan Opera K060956 Siemens Magnetomn C! K043030 USA Instruments Magna 5000 K(994345… | 2006 |
| * | K043030 | Magnetom C! MR SystemSummary page 1…ice(s) Esaote G-scan K042236 Esaote E-scan Opera K060956 Siemens Magnetomn C! K043030 USA Instruments Magna 5000 K(994345 Phased Array CTh Spin… | 2004 |
| * | K994345 | Magna 5000 Phased Array CTL Spine CoilSummary page 4…CTL Spine Coil K994345, available on… | 2000 |
What descends from it? (34)
See all 342 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 15 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 7 of the 34 ancestors have a recall of any class.
- Of its descendants, K080968 (Esaote, S.p.A., 2008) has gone furthest, with 24 descendants of its own.
- 4 other devices also cite its predicate K042236.
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.
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 and 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 and imaging portions of the spinal column, including the cervical and lumbo-sacral…
Read the full statement (130 words)
S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and 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 and imaging portions of the spinal column, including the cervical and lumbo-sacral sections.
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 spin-lattice relaxation time (TI), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063207 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063207: S-Scan Mri System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063207
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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