510(k) · Cleared
ClearedG-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 Oct 4, 2004 as substantially equivalent to K032121 (Esaote, S.p.A., 2003) and 4 other predicates after a 47-day review. Its family tree reaches back 6 generations to 1991. 45 later devices descend from it.
- Decided
- Oct 4, 2004
- Review
- 47 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K911667 (1991). 27 ancestors in all. 45 later devices descend from it, 5 citing it directly.
- Root · 6 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 5 generations backK963262 Artoscan MBiosound, Inc. · 1997
- 4 generations backK981358 Artoscan SBiosound Esaote, Inc. · 1998
- 3 generations backK990968 E-SCANBiosound Esaote, Inc. · 1999
- 2 generations backK020164 E-Scan XQBiosound Esaote, Inc. · 2002
- 1 generation backK032121 Modification to E-Scan XQEsaote, S.p.A. · 2003
- This deviceK042236 G-SCANEsaote, S.p.A. · 2004
- Descendant · cites it directly · 43 of its ownK060956 G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006
- Descendant · cites it directly · 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
- 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
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · See all- K060956G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006 · cites it directly43descendants
- K063207S-Scan Mri SystemEsaote, S.p.A. · 2006 · cites it directly34descendants
- K061429Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006 · 2 generations on32descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K911667 | Hitachi MRP-7000 Magnetic Rosonance Device | Hitachi Medical Systems America, Inc. | 1991 | 2 |
| −5 | K963262 | Artoscan M | Biosound, Inc. | 1997 | — |
| −4 | K981358 | Artoscan S | Biosound Esaote, Inc. | 1998 | — |
| −3 | K990968 | E-SCAN | Biosound Esaote, Inc. | 1999 | — |
| −2 | K020164 | E-Scan XQ | Biosound Esaote, Inc. | 2002 | — |
| −1 | K032121 | Modification to E-Scan XQ | Esaote, S.p.A. | 2003 | — |
| 0 (this device) | 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 | — |
| +1 | 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 | — |
| +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 | — |
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 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K032121 | Modification to E-Scan XQSummary page 1…ame Common name Class Product code Manufacturer K number E-scan XQ System, nuclear II LNH ESAOTE S.P.A. K032121 magnetic resonance imaging AIRIS II System, nuclear 11 LNH HITACHI… | 2003 |
| * | K001334 | Hitachi Airis IISummary page 1…OTE S.P.A. K032121 magnetic resonance imaging AIRIS II System, nuclear 11 LNH HITACHI MEDICAL K001334 magnetic resonance SYSTEMS imaging MAGNA SL System, nuclear… | 2000 |
| * | K940894 | Magna SLSummary page 1…magnetic resonance SYSTEMS imaging MAGNA SL System, nuclear II LNH MAGNA-LAB K940894 magnetic resonance imaging Magna 5000 Coil, Magnetic II MOS USA INSTRUMEN… | 1994 |
| * | K994345 | Magna 5000 Phased Array CTL Spine CoilSummary page 1…MAGNA-LAB K940894 magnetic resonance imaging Magna 5000 Coil, Magnetic II MOS USA INSTRUMENTS K994345 Phased Array Resonance, Specialty '2TL Spine -'oil UROLOGIC Table, radiographic, it IXR PCK ELECTRONIC… | 2000 |
| * | K011311 | UrologicSummary page 1…USA INSTRUMENTS K994345 Phased Array Resonance, Specialty '2TL Spine -'oil UROLOGIC Table, radiographic, it IXR PCK ELECTRONIC K011311 tilting INDUSTRY '01.92(a)(4)… | 2001 |
What descends from it? (45)
See all 455 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 13 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 6 of the 27 ancestors have a recall of any class.
- Of its descendants, K060956 (Esaote, S.p.A., 2006) has gone furthest, with 43 descendants of its own.
- 3 other devices also cite its predicate K032121.
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?
G-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, thoracic and…
Read the full statement (131 words)
G-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, thoracic and lumbo-sacral sections.
G-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 (T1), 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/K042236 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042236: G-SCAN.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042236
Report an extraction error
Are you the manufacturer?
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