510(k) · Cleared
ClearedO-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 Jan 22, 2019 as substantially equivalent to K092469 (Esaote, S.p.A., 2009) after a 25-day review. Its family tree reaches back 11 generations to 1991.
- Decided
- Jan 22, 2019
- Review
- 25 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K911667 (1991). 45 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 7 generations between
- 3 generations backK061429 Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006
- 2 generations backK080968 S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan…Esaote, S.p.A. · 2008
- 1 generation backK092469 O-Scan MR SystemEsaote, S.p.A. · 2009
- This deviceK183685 O-ScanEsaote, S.p.A. · 2019
Show all 11 generations
- Root · 11 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 10 generations backK963262 Artoscan MBiosound, Inc. · 1997
- 9 generations backK981358 Artoscan SBiosound Esaote, Inc. · 1998
- 8 generations backK990968 E-SCANBiosound Esaote, Inc. · 1999
- 7 generations backK020164 E-Scan XQBiosound Esaote, Inc. · 2002
- 6 generations backK032121 Modification to E-Scan XQEsaote, S.p.A. · 2003
- 5 generations backK042236 G-SCANEsaote, S.p.A. · 2004
- 4 generations backK060956 G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006
- 3 generations backK061429 Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006
- 2 generations backK080968 S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan…Esaote, S.p.A. · 2008
- 1 generation backK092469 O-Scan MR SystemEsaote, S.p.A. · 2009
- This deviceK183685 O-ScanEsaote, S.p.A. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K911667 | Hitachi MRP-7000 Magnetic Rosonance Device | Hitachi Medical Systems America, Inc. | 1991 | 2 |
| −10 | K963262 | Artoscan M | Biosound, Inc. | 1997 | — |
| −9 | K981358 | Artoscan S | Biosound Esaote, Inc. | 1998 | — |
| −8 | K990968 | E-SCAN | Biosound Esaote, Inc. | 1999 | — |
| −7 | K020164 | E-Scan XQ | Biosound Esaote, Inc. | 2002 | — |
| −6 | K032121 | Modification to E-Scan XQ | Esaote, S.p.A. | 2003 | — |
| −5 | K042236 | G-SCAN | Esaote, S.p.A. | 2004 | — |
| −4 | K060956 | G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan… | Esaote, S.p.A. | 2006 | — |
| −3 | K061429 | Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan Opera | Esaote, S.p.A. | 2006 | — |
| −2 | K080968 | S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan Opera | Esaote, S.p.A. | 2008 | — |
| −1 | K092469 | O-Scan MR System | Esaote, S.p.A. | 2009 | — |
| 0 (this device) | K183685 | O-Scan | Esaote, S.p.A. | 2019 | — |
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 |
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?
No later submission names this one as a predicate yet.
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 28 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 9 of the 45 ancestors have a recall of any class.
- 3 other devices also cite its predicate K092469.
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. 2019, 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?
O-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal, coronal and oblique section images of limbs and joints. It is designed for imaging portions of the arm, including hand, wrist, forearm, and elbow, but excluding the upper part of the arm and portions of the leg, including foot, ankle, calf, and knee, but excluding the thigh. The M.R. images produced by O-scan correspond to the spatial distribution of the protons (hydrogen…
Read the full statement (121 words)
O-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal, coronal and oblique section images of limbs and joints. It is designed for imaging portions of the arm, including hand, wrist, forearm, and elbow, but excluding the upper part of the arm and portions of the leg, including foot, ankle, calf, and knee, but excluding the thigh.
The M.R. images produced by O-scan correspond to the spatial distribution of the protons (hydrogen nuclei) which verify the properties of magnetic resonance and depend on the MR parameters spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nucleus density, flow velocity and “chemical shift”. When interpreted by a medical expert trained in use of MR equipment, the images can provide diagnostically useful information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183685 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183685: O-Scan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183685
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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