510(k) · Cleared
ClearedE-Scan XQ
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 Feb 12, 2002 as substantially equivalent to K963262 (Biosound, Inc., 1997) and 3 other predicates after a 26-day review. Its family tree reaches back 4 generations to 1991. 48 later devices descend from it.
- Decided
- Feb 12, 2002
- Review
- 26 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K911667 (1991). 17 ancestors in all. 48 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 3 generations backK963262 Artoscan MBiosound, Inc. · 1997
- 2 generations backK981358 Artoscan SBiosound Esaote, Inc. · 1998
- 1 generation backK990968 E-SCANBiosound Esaote, Inc. · 1999
- This deviceK020164 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
- Descendant · 2 generations on · 32 of its ownK061429 Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 48 · See all- 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
- K061429Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006 · 2 generations on32descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K911667 | Hitachi MRP-7000 Magnetic Rosonance Device | Hitachi Medical Systems America, Inc. | 1991 | 2 |
| −3 | K963262 | Artoscan M | Biosound, Inc. | 1997 | — |
| −2 | K981358 | Artoscan S | Biosound Esaote, Inc. | 1998 | — |
| −1 | K990968 | E-SCAN | Biosound Esaote, Inc. | 1999 | — |
| 0 (this device) | 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 | — |
| +2 | K061429 | Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan Opera | 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 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K963262 | Artoscan MSummary page 1…ce diagnostic device Classification Name(s): System, Nuclear Magnetic Resonance Imaging Classification Number: 90LNH 807.92(a)(3) Predicate Device(s) Esaote Artoscan M K963262 Esaote E-Scan K990968 Esaote E-Scan K001894 Esaote Hip Coil K012728 16 807.92(a)(3) Intended Use(s) The E-scan,… | 1997 |
| * | K990968 | E-SCANSummary page 1…lassification Name(s): System, Nuclear Magnetic Resonance Imaging Classification Number: 90LNH 807.92(a)(3) Predicate Device(s) Esaote Artoscan M K963262 Esaote E-Scan K990968 Esaote E-Scan K001894 Esaote Hip Coil K012728 16 807.92(a)(3) Intended Use(s) The E-scan, is intended for diagn… | 1999 |
| * | K001894 | Modification to E-ScanSummary page 1…System, Nuclear Magnetic Resonance Imaging Classification Number: 90LNH 807.92(a)(3) Predicate Device(s) Esaote Artoscan M K963262 Esaote E-Scan K990968 Esaote E-Scan K001894 Esaote Hip Coil K012728 16 807.92(a)(3) Intended Use(s) The E-scan, is intended for diagnostic nuclear magnetic… | 2000 |
| * | K012728 | E-Scan Mri SystemSummary page 1…c Resonance Imaging Classification Number: 90LNH 807.92(a)(3) Predicate Device(s) Esaote Artoscan M K963262 Esaote E-Scan K990968 Esaote E-Scan K001894 Esaote Hip Coil K012728 16 807.92(a)(3) Intended Use(s) The E-scan, is intended for diagnostic nuclear magnetic resonance imaging of th… | 2001 |
What descends from it? (48)
See all 482 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 11 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 3 of the 17 ancestors have a recall of any class.
- Of its descendants, K032121 (Esaote, S.p.A., 2003) has gone furthest, with 47 descendants of its own.
- 2 other devices also cite its predicate K963262.
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 XQ is intended for diagnostic nuclear magnetic resonance imaging of the hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm and forearm. 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…
Read the full statement (101 words)
The E-scan XQ is intended for diagnostic nuclear magnetic resonance imaging of the hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm and forearm. 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.
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/K020164 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020164: E-Scan XQ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020164
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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