510(k) · Cleared
Recalled · Class II · 2018Mylabseven, Mylabalpha
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 Sep 12, 2014 as substantially equivalent to K111302 (Esaote, S.p.A., 2011) and 9 other predicates after a 51-day review. Its family tree reaches back 14 generations to 1995. 1 of the 178 devices in its family, counting itself, has a Class I recall. 19 later devices descend from it. It has been recalled 3 times.
- Decided
- Sep 12, 2014
- Review
- 51 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 3
- Predicates
- 10
Its longest line of descent runs back 14 generations to K935595 (1995). 158 ancestors in all, the oldest K891689 (1989). 19 later devices descend from it, 3 citing it directly. 1 of the 178 devices in this family, counting this one, has a Class I recall.
- Root · 14 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 10 generations between
- 3 generations backK091009 MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY…Esaote, S.p.A. · 2009
- 2 generations backK110688 MylabgoldEsaote · 2011 · Recalled
- 1 generation backK132231 Mylabseven, MylabalphaEsaote, S.p.A. · 2013
- This deviceK142008 Mylabseven, MylabalphaEsaote, S.p.A. · 2014
- Descendant · cites it directly · 12 of its ownK153277 6200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2016
- Descendant · 2 generations on · 9 of its ownK163082 6200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2017 · Recalled
- Descendant · 3 generations on · 8 of its ownK173291 6440 Ultrasound SystemEsaote, S.p.A. · 2018
- Descendant · 4 generations on · 4 of its ownK230179 6440 MyLabX90Esaote, S.p.A. · 2023 · Recalled
- Descendant · 4 generations on · 4 of its ownK192157 6450 Ultrasound systemEsaote, S.p.A. · 2019
Show all 14 generations
- Root · 14 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 13 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 12 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 11 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 10 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 9 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 8 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 7 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 6 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 5 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 4 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 3 generations backK091009 MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY…Esaote, S.p.A. · 2009
- 2 generations backK110688 MylabgoldEsaote · 2011 · Recalled
- 1 generation backK132231 Mylabseven, MylabalphaEsaote, S.p.A. · 2013
- This deviceK142008 Mylabseven, MylabalphaEsaote, S.p.A. · 2014
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K070106 VV Fluoro 3D2 generations back · 2007
Most influential descendants
Showing 5 of 19 · See all- K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2016 · cites it directly12descendants
- K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2017 · 2 generations on9descendants
- K1732916440 Ultrasound SystemEsaote, S.p.A. · 2018 · 3 generations on8descendants
- K2301796440 MyLabX90Esaote, S.p.A. · 2023 · 4 generations on4descendants
- K1921576450 Ultrasound systemEsaote, S.p.A. · 2019 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −13 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −12 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −11 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −10 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −9 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −8 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −7 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −6 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −5 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −4 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −3 | K091009 | MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY… | Esaote, S.p.A. | 2009 | — |
| −2 | K110688 | Mylabgold | Esaote | 2011 | 1 |
| −1 | K132231 | Mylabseven, Mylabalpha | Esaote, S.p.A. | 2013 | — |
| 0 (this device) | K142008 | Mylabseven, Mylabalpha | Esaote, S.p.A. | 2014 | — |
| +1 | K153277 | 6200 Ultrasound System and 6250 Ultrasound System | Esaote, S.p.A. | 2016 | — |
| +2 | K163082 | 6200 Ultrasound System and 6250 Ultrasound System | Esaote, S.p.A. | 2017 | 2 |
| +3 | K173291 | 6440 Ultrasound System | Esaote, S.p.A. | 2018 | — |
| +4 | K230179 | 6440 MyLabX90 | Esaote, S.p.A. | 2023 | 1 |
| +4 | K192157 | 6450 Ultrasound system | Esaote, S.p.A. | 2019 | — |
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 | 6 | 0 |
| 1998 | 7 | 0 |
| 1999 | 14 | 0 |
| 2000 | 14 | 0 |
| 2001 | 13 | 0 |
| 2002 | 11 | 0 |
| 2003 | 14 | 0 |
| 2004 | 17 | 0 |
| 2005 | 14 | 0 |
| 2006 | 7 | 0 |
| 2007 | 3 | 1 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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.
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? (10)
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 |
|---|---|---|---|
| * | K111302 | Mylabseven, MylabalphaSummary page 5…[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border Previously cleared via k111302, K132231, K132466 Prescription Use Only Per 21 CFR 801 Part D Concurren… | 2011 |
| * | K132231 | Mylabseven, MylabalphaSummary page 5…ludes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border Previously cleared via k111302, K132231, K132466 Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH… | 2013 |
| * | K132466 | Mylabseven 6400, Mylabalpha 7400Summary page 5…trast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border Previously cleared via k111302, K132231, K132466 Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH… | 2013 |
| * | K081794 | Model 7340 Ultrasound SystemSummary page 36…saote K111302, K132231, 7400 K132466 7340 Esaote K081794, K091009, K110688 (VDRWH6S$8SJUDGH N… | 2008 |
| * | K091009 | MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Summary page 36…K111302, K132231, 7400 K132466 7340 Esaote K081794, K091009, K110688 (VDRWH6S$8SJUDGH N… | 2009 |
| * | K110688 | MylabgoldSummary page 36…K132466 7340 Esaote K081794, K091009, K110688 (VDRWH6S$8SJUDGH N 3DJHRI 510… | 2011 |
| * | K051308 | Mylab 70 Ultrasound Imaging SystemSummary page 37…ission 6400 and 7400 Upgrade Esaote, S.p.A. Device Owner 510(k) 6150 Esaote K051308, K052805, K060827, K081386,… | 2005 |
| * | K052805 | MYLAB30, 50 and 70 Systems Upgrade, Models 7300, 7350, 6150Summary page 37…00 and 7400 Upgrade Esaote, S.p.A. Device Owner 510(k) 6150 Esaote K051308, K052805, K060827, K081386,… | 2005 |
| * | K060827 | MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100Summary page 37…e Owner 510(k) 6150 Esaote K051308, K052805, K060827, K081386, K091009 807.92(a)(4)… | 2006 |
| * | K081386 | Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Summary page 37…Owner 510(k) 6150 Esaote K051308, K052805, K060827, K081386, K091009 807.92(a)(4) Device D… | 2008 |
What descends from it? (19)
See all 193 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 |
|---|---|---|---|---|
| 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 · 2 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 36 of the 158 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K153277 (Esaote, S.p.A., 2016) has gone furthest, with 12 descendants of its own.
- 5 other devices also cite its predicate K111302.
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. 2014, 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 abdomninal, Laparoscopic and Other: Urologic. The 6400 system provides imaging for guidance of biopsy and imaging to…
Read the full statement (149 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 abdomninal, Laparoscopic and Other: Urologic. The 6400 system 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 abdomninal and Other: Urologic. The 7400 system 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142008: Mylabseven, Mylabalpha.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142008
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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