510(k) · Cleared
Recalled · Class II · 20206400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Esaote, S.p.A. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jul 19, 2016 as substantially equivalent to K142008 (Esaote, S.p.A., 2014) and 5 other predicates after a 64-day review. Its family tree reaches back 16 generations to 1995. 1 of the 172 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it. It has been recalled 5 times.
- Decided
- Jul 19, 2016
- Review
- 64 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 5
- Predicates
- 6
Its longest line of descent runs back 16 generations to K935595 (1995). 167 ancestors in all, the oldest K891689 (1989). 4 later devices descend from it, 4 citing it directly. 1 of the 172 devices in this family, counting this one, has a Class I recall.
- Root · 16 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 12 generations between
- 3 generations backK132231 Mylabseven, MylabalphaEsaote, S.p.A. · 2013
- 2 generations backK141486 Mylabsix Ultrasound SystemEsaote Europe B.V. · 2014
- 1 generation backK142077 MylabgammaEsaote, S.p.A. · 2014 · Recalled
- This deviceK161359 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A. · 2016
- Descendant · cites it directly · 0 of its ownK191072 7410 Ultrasound System (MyLabSigma)Esaote, S.p.A. · 2019
- Descendant · cites it directly · 0 of its ownK190989 6400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A. · 2019
- Descendant · cites it directly · 0 of its ownK190447 7400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A. · 2019
- Descendant · cites it directly · 0 of its ownK162290 MyLabSix CrystaLineEsaote, S.p.A. · 2016
Show all 16 generations
- Root · 16 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 15 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 14 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 13 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 12 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 11 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 10 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 9 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 8 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 7 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 6 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 5 generations backK091009 MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY…Esaote, S.p.A. · 2009
- 4 generations backK110688 MylabgoldEsaote · 2011 · Recalled
- 3 generations backK132231 Mylabseven, MylabalphaEsaote, S.p.A. · 2013
- 2 generations backK141486 Mylabsix Ultrasound SystemEsaote Europe B.V. · 2014
- 1 generation backK142077 MylabgammaEsaote, S.p.A. · 2014 · Recalled
- This deviceK161359 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A. · 2016
Class I recalls in this family
- K070106 VV Fluoro 3D3 generations back · 2007
Most influential descendants
Showing 4 of 4 · See all- K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A. · 2019 · cites it directly0descendants
- K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A. · 2019 · cites it directly0descendants
- K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A. · 2019 · cites it directly0descendants
- K162290MyLabSix CrystaLineEsaote, S.p.A. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −15 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −14 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −13 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −12 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −11 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −10 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −9 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −8 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −7 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −6 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −5 | K091009 | MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY… | Esaote, S.p.A. | 2009 | — |
| −4 | K110688 | Mylabgold | Esaote | 2011 | 1 |
| −3 | K132231 | Mylabseven, Mylabalpha | Esaote, S.p.A. | 2013 | — |
| −2 | K141486 | Mylabsix Ultrasound System | Esaote Europe B.V. | 2014 | — |
| −1 | K142077 | Mylabgamma | Esaote, S.p.A. | 2014 | 3 |
| 0 (this device) | K161359 | 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System | Esaote, S.p.A. | 2016 | — |
| +1 | K191072 | 7410 Ultrasound System (MyLabSigma) | Esaote, S.p.A. | 2019 | — |
| +1 | K190989 | 6400 Ultrasound System (MyLabX6, MyLabX7) | Esaote, S.p.A. | 2019 | — |
| +1 | K190447 | 7400 Ultrasound Systems | Navigant Consulting - on Behalf of Esaote S.P.A. | 2019 | — |
| +1 | K162290 | MyLabSix CrystaLine | Esaote, S.p.A. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 6 | 0 |
| 1996 | 1 | 0 |
| 1997 | 7 | 0 |
| 1998 | 7 | 0 |
| 1999 | 14 | 0 |
| 2000 | 14 | 0 |
| 2001 | 13 | 0 |
| 2002 | 12 | 0 |
| 2003 | 15 | 0 |
| 2004 | 17 | 0 |
| 2005 | 15 | 0 |
| 2006 | 8 | 0 |
| 2007 | 3 | 1 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 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.
1 device in this family has a Class I recall. 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 IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K142008 | Mylabseven, MylabalphaSummary page 5…/4D [7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border Previously cleared via K142008 and to be cleared with this submission 3UHVFULSWLRQ8VH2QO\3HU&)… | 2014 |
| * | K142077 | MylabgammaSummary page 7…D/4D [7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border Previously cleared via K142077 and to be cleared with this submission 3UHVFULSWLRQ8VH2QO\3HU&)5… | 2014 |
| * | K110688 | MylabgoldSummary page 55…7400 – MyLabAlpha Primary K142077 7410 – MyLabGamma Esaote S.p.A. Reference K110688 7340 – MyLab30 Gold Esaote S.p.A. Reference K061961 ART.LAB… | 2011 |
| * | K061961 | Art Lab SoftwareSummary page 55…7410 – MyLabGamma Esaote S.p.A. Reference K110688 7340 – MyLab30 Gold Esaote S.p.A. Reference K061961 ART.LAB Esaote Europe B.V. Reference K101605 8100 – MyLabOne… | 2006 |
| * | K101605 | Mylabone Ultrasound SystemSummary page 55…7340 – MyLab30 Gold Esaote S.p.A. Reference K061961 ART.LAB Esaote Europe B.V. Reference K101605 8100 – MyLabOne Esaote Europe B.V. Reference K113156 SonoSite Edge… | 2010 |
| * | K113156 | Sonosite Edge Ultrasound SystemSummary page 55…ART.LAB Esaote Europe B.V. Reference K101605 8100 – MyLabOne Esaote Europe B.V. Reference K113156 SonoSite Edge Fujifilm SonoSite, Inc. Additional substantial equivalence information is provided in th… | 2011 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 8, 2020 | Class II | Z-3052-2020 | Device Design | The AC/DC adapter (power supply) of the portable ultrasound systems listed below that may result in the connector heating up, generating smoke and melting. This condition is caused by the mechanical stress of the connection between the… |
| Sep 8, 2020 | Class II | Z-3053-2020 | Device Design | The AC/DC adapter (power supply) of the portable ultrasound systems listed below that may result in the connector heating up, generating smoke and melting. This condition is caused by the mechanical stress of the connection between the… |
| Jun 11, 2018 | Class II | Z-0204-2019 | Software design | The probe power monitoring settings have been found to be not appropriate under specific operating conditions when connected to the devices listed below. This issue may result in overheating of the probe head. The probe power monitoring… |
| Jun 11, 2018 | Class II | Z-0205-2019 | Software design | The probe power monitoring settings have been found to be not appropriate under specific operating conditions when connected to the devices listed below. This issue may result in overheating of the probe head. The probe power monitoring… |
| Jun 11, 2018 | Class II | Z-0206-2019 | Software design | The probe power monitoring settings have been found to be not appropriate under specific operating conditions when connected to the devices listed below. This issue may result in overheating of the probe head. The probe power monitoring… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K070106VV Fluoro 3DBrainlab AG · 2007 · 3 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 40 of the 167 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K191072 (Esaote, S.p.A., 2019) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K142008.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, 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 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
Esaote’s Model 6400 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. Model 6400 provides imaging for guidance of biopsy and imaging to…
Read the full statement (222 words)
Esaote’s Model 6400 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. Model 6400 provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
Esaote’s Model 7400 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. Model 7400 provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
Esaote’s Model 7410 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. Model 7410 provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161359 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161359: 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161359
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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