510(k) · Cleared
ClearedO-Scan MR 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 Dec 23, 2009 as substantially equivalent to K040877 (Esaote, S.p.A., 2004) and 2 other predicates after a 134-day review. Its family tree reaches back 10 generations to 1991. 18 later devices descend from it.
- Decided
- Dec 23, 2009
- Review
- 134 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K911667 (1991). 44 ancestors in all. 18 later devices descend from it, 4 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 deviceK092469 O-Scan MR SystemEsaote, S.p.A. · 2009
- Descendant · cites it directly · 15 of its ownK110238 G-SCANEsaote, S.p.A. · 2011
- Descendant · 2 generations on · 14 of its ownK111803 G-SCANEsaote, S.p.A. · 2011
- Descendant · 3 generations on · 11 of its ownK122006 G-Scan BrioEsaote, S.p.A. · 2012
- Descendant · 4 generations on · 10 of its ownK133490 G-Scan BrioEsaote, S.p.A. · 2013
- Descendant · 3 generations on · 9 of its ownK142421 G-scan BrioEsaote, S.p.A. · 2015 · Recalled
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 deviceK092469 O-Scan MR SystemEsaote, S.p.A. · 2009
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K110238G-SCANEsaote, S.p.A. · 2011 · cites it directly15descendants
- K111803G-SCANEsaote, S.p.A. · 2011 · 2 generations on14descendants
- K122006G-Scan BrioEsaote, S.p.A. · 2012 · 3 generations on11descendants
- K133490G-Scan BrioEsaote, S.p.A. · 2013 · 4 generations on10descendants
- K142421G-scan BrioEsaote, S.p.A. · 2015 · 3 generations on9descendants
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) | K092469 | O-Scan MR System | Esaote, S.p.A. | 2009 | — |
| +1 | K110238 | G-SCAN | Esaote, S.p.A. | 2011 | — |
| +2 | K111803 | G-SCAN | Esaote, S.p.A. | 2011 | — |
| +3 | K122006 | G-Scan Brio | Esaote, S.p.A. | 2012 | — |
| +4 | K133490 | G-Scan Brio | Esaote, S.p.A. | 2013 | — |
| +3 | K142421 | G-scan Brio | Esaote, S.p.A. | 2015 | 1 |
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 |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2019 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K040877 | Artoscan CSummary page 1…cate Device(s) Tradename Common name Class Product code Manufacturer K number C-scan System, nuclear magnetic II LNH ESAOTE S.P.A. K040877 resonance imaging S-scan System, nuclear magnetic II LNH ESAOTE S.P.A. K080968 resonance i… | 2004 |
| * | K080968 | S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan OperaSummary page 1…System, nuclear magnetic II LNH ESAOTE S.P.A. K040877 resonance imaging S-scan System, nuclear magnetic II LNH ESAOTE S.P.A. K080968 resonance imaging AIRIS II System, nuclear magnetic II LNH HITACHII MEDICAL K001334 _________resonance… | 2008 |
| * | K001334 | Hitachi Airis IISummary page 1…System, nuclear magnetic II LNH ESAOTE S.P.A. K080968 resonance imaging AIRIS II System, nuclear magnetic II LNH HITACHII MEDICAL K001334 _________resonance imaging ___ ______SYSTEMS 0-Scan 510(k) 8712009… | 2000 |
What descends from it? (18)
See all 184 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 18 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, K110238 (Esaote, S.p.A., 2011) has gone furthest, with 15 descendants of its own.
- 1 other device also cites its predicate K040877.
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. 2009, 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?
0-scan is a Magnetic Resonance (MIR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs and joints. It is intended for imaging portions of the arm, including the hand, wrist, forearm and elbow, but excluding the upper arm, and imaging portions of the leg, including the foot, ankle, calf and knee, but excluding the thigh. 0-scan images correspond to the spatial distribution of protons (hydrogen nuclei)…
Read the full statement (119 words)
0-scan is a Magnetic Resonance (MIR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs and joints. It is intended for imaging portions of the arm, including the hand, wrist, forearm and elbow, but excluding the upper arm, and imaging portions of the leg, including the foot, ankle, calf and knee, but excluding the thigh.
0-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 informnation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092469 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092469: O-Scan MR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092469
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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