510(k) · Cleared
ClearedE-SCAN
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosound Esaote, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on May 27, 1999 as substantially equivalent to K981358 (Biosound Esaote, Inc., 1998) after a 65-day review. Its family tree reaches back 3 generations to 1991. 49 later devices descend from it.
- Decided
- May 27, 1999
- Review
- 65 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K911667 (1991). 14 ancestors in all. 49 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 2 generations backK963262 Artoscan MBiosound, Inc. · 1997
- 1 generation backK981358 Artoscan SBiosound Esaote, Inc. · 1998
- This deviceK990968 E-SCANBiosound Esaote, Inc. · 1999
- Descendant · cites it directly · 48 of its ownK020164 E-Scan XQBiosound Esaote, Inc. · 2002
- Descendant · cites it directly · 47 of its ownK032121 Modification to E-Scan XQEsaote, S.p.A. · 2003
- Descendant · 2 generations on · 45 of its ownK042236 G-SCANEsaote, S.p.A. · 2004
- Descendant · 2 generations on · 43 of its ownK060956 G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006
- Descendant · 3 generations on · 34 of its ownK063207 S-Scan Mri SystemEsaote, S.p.A. · 2006
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 49 · See all- K020164E-Scan XQBiosound Esaote, Inc. · 2002 · cites it directly48descendants
- K032121Modification to E-Scan XQEsaote, S.p.A. · 2003 · cites it directly47descendants
- K042236G-SCANEsaote, S.p.A. · 2004 · 2 generations on45descendants
- K060956G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006 · 2 generations on43descendants
- K063207S-Scan Mri SystemEsaote, S.p.A. · 2006 · 3 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K911667 | Hitachi MRP-7000 Magnetic Rosonance Device | Hitachi Medical Systems America, Inc. | 1991 | 2 |
| −2 | K963262 | Artoscan M | Biosound, Inc. | 1997 | — |
| −1 | K981358 | Artoscan S | Biosound Esaote, Inc. | 1998 | — |
| 0 (this device) | K990968 | E-SCAN | Biosound Esaote, Inc. | 1999 | — |
| +1 | K020164 | E-Scan XQ | Biosound Esaote, Inc. | 2002 | — |
| +1 | K032121 | Modification to E-Scan XQ | Esaote, S.p.A. | 2003 | — |
| +2 | K042236 | G-SCAN | Esaote, S.p.A. | 2004 | — |
| +2 | K060956 | G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan… | Esaote, S.p.A. | 2006 | — |
| +3 | K063207 | S-Scan Mri System | Esaote, S.p.A. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 7 | 0 |
| 2013 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2019 | 4 | 0 |
| 2021 | 1 | 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? (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 |
|---|---|---|---|
| * | K981358 | Artoscan SSummary page 1…nance diagnostic device Classification Name(s): System, Nuclear Magnetic Resonance Imaging Classification Number: P 807.92(a)(3) Predicate Device(s) Esaote Artoscan S K981358 Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table. === Page… | 1998 |
What descends from it? (49)
See all 493 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 8 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 14 ancestors have a recall of any class.
- Of its descendants, K020164 (Biosound Esaote, Inc., 2002) has gone furthest, with 48 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.
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 E-Scan is intended for diagnostic nuclear magnetic resonance imaging of the hip, leg, knee, ankle, foot, shoulder, elbow, forearm, wrist and hand. The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and…
Read the full statement (176 words)
The E-Scan is intended for diagnostic nuclear magnetic resonance imaging of the hip, leg, knee, ankle, foot, shoulder, elbow, forearm, wrist and hand. The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.
The system preliminarily named “Artoscan S” is going to be commercialized under the trade name “E-Scan”. The changes performed, with respect to the cleared version, are due to the optimization process of the system, in particular in relation to an improvement of the accessibility inside the gantry and therefore toward a greater patient comfort. The intended use of the modified device has not changed as a result of the modifications nor such modifications alter its fundamental scientific technology.
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/K990968 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990968: E-SCAN.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990968
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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