510(k) · Cleared
ClearedA-Channels Lumbat Spine Coils 17; 4-Channels Lumbar Spine Coils 18
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 Apr 8, 2011 as substantially equivalent to K080968 (Esaote, S.p.A., 2008) after a 16-day review. Its family tree reaches back 10 generations to 1991. 11 later devices descend from it.
- Decided
- Apr 8, 2011
- Review
- 16 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K911667 (1991). 44 ancestors in all. 11 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 6 generations between
- 3 generations backK060956 G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006
- 2 generations backK061429 Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006
- 1 generation backK080968 S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan…Esaote, S.p.A. · 2008
- This deviceK110802 A-Channels Lumbat Spine Coils 17; 4-Channels Lumbar Spine Coils 18Esaote, S.p.A. · 2011
- Descendant · cites it directly · 10 of its ownK121650 S-SCANEsaote, S.p.A. · 2012
- Descendant · 2 generations on · 9 of its ownK131996 S-SCANEsaote, S.p.A. · 2013
- Descendant · 3 generations on · 8 of its ownK151668 S-scanEsaote, S.p.A. · 2015
- Descendant · 4 generations on · 7 of its ownK153039 MRI Dynamic Analysis PlusEsaote, S.p.A. · 2016
- Descendant · 5 generations on · 6 of its ownK161238 S-scanEsaote, S.p.A. · 2016
Show all 10 generations
- Root · 10 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 9 generations backK963262 Artoscan MBiosound, Inc. · 1997
- 8 generations backK981358 Artoscan SBiosound Esaote, Inc. · 1998
- 7 generations backK990968 E-SCANBiosound Esaote, Inc. · 1999
- 6 generations backK020164 E-Scan XQBiosound Esaote, Inc. · 2002
- 5 generations backK032121 Modification to E-Scan XQEsaote, S.p.A. · 2003
- 4 generations backK042236 G-SCANEsaote, S.p.A. · 2004
- 3 generations backK060956 G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006
- 2 generations backK061429 Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006
- 1 generation backK080968 S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan…Esaote, S.p.A. · 2008
- This deviceK110802 A-Channels Lumbat Spine Coils 17; 4-Channels Lumbar Spine Coils 18Esaote, S.p.A. · 2011
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K121650S-SCANEsaote, S.p.A. · 2012 · cites it directly10descendants
- K131996S-SCANEsaote, S.p.A. · 2013 · 2 generations on9descendants
- K151668S-scanEsaote, S.p.A. · 2015 · 3 generations on8descendants
- K153039MRI Dynamic Analysis PlusEsaote, S.p.A. · 2016 · 4 generations on7descendants
- K161238S-scanEsaote, S.p.A. · 2016 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K911667 | Hitachi MRP-7000 Magnetic Rosonance Device | Hitachi Medical Systems America, Inc. | 1991 | 2 |
| −9 | K963262 | Artoscan M | Biosound, Inc. | 1997 | — |
| −8 | K981358 | Artoscan S | Biosound Esaote, Inc. | 1998 | — |
| −7 | K990968 | E-SCAN | Biosound Esaote, Inc. | 1999 | — |
| −6 | K020164 | E-Scan XQ | Biosound Esaote, Inc. | 2002 | — |
| −5 | K032121 | Modification to E-Scan XQ | Esaote, S.p.A. | 2003 | — |
| −4 | K042236 | G-SCAN | Esaote, S.p.A. | 2004 | — |
| −3 | K060956 | G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan… | Esaote, S.p.A. | 2006 | — |
| −2 | K061429 | Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan Opera | 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 | — |
| 0 (this device) | K110802 | A-Channels Lumbat Spine Coils 17; 4-Channels Lumbar Spine Coils 18 | Esaote, S.p.A. | 2011 | — |
| +1 | K121650 | S-SCAN | Esaote, S.p.A. | 2012 | — |
| +2 | K131996 | S-SCAN | Esaote, S.p.A. | 2013 | — |
| +3 | K151668 | S-scan | Esaote, S.p.A. | 2015 | — |
| +4 | K153039 | MRI Dynamic Analysis Plus | Esaote, S.p.A. | 2016 | — |
| +5 | K161238 | S-scan | Esaote, S.p.A. | 2016 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 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.
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121650 | S-SCAN | 2012 | 10 |
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 20 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 9 of the 44 ancestors have a recall of any class.
- Of its descendants, K121650 (Esaote, S.p.A., 2012) has gone furthest, with 10 descendants of its own.
- 6 other devices also cite its predicate K080968.
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. 2011, 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 transverse, 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 the cervical spine and the lumbar spine sections as portions of the spinal…
Read the full statement (133 words)
S-scan is a Magnetic Resonance (MR) system that produces transverse, 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 the cervical spine and the lumbar spine 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 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/K110802 · printed Nov 3, 2026
Cite this page
510(k) Report. “K110802: A-Channels Lumbat Spine Coils 17; 4-Channels Lumbar Spine Coils 18.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K110802
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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