510(k) · Cleared
ClearedMylabsix Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Esaote Europe B.V. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jul 11, 2014 as substantially equivalent to K111302 (Esaote, S.p.A., 2011) and 3 other predicates after a 36-day review. Its family tree reaches back 14 generations to 1995. 1 of the 167 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it.
- Decided
- Jul 11, 2014
- Review
- 36 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 14 generations to K935595 (1995). 158 ancestors in all, the oldest K891689 (1989). 8 later devices descend from it, 4 citing it directly. 1 of the 167 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 deviceK141486 Mylabsix Ultrasound SystemEsaote Europe B.V. · 2014
- Descendant · cites it directly · 5 of its ownK142077 MylabgammaEsaote, S.p.A. · 2014 · Recalled
- Descendant · 2 generations on · 4 of its ownK161359 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A. · 2016 · Recalled
- Descendant · cites it directly · 1 of its ownK161168 MyLabSix Ultrasound SystemEsaote Europe B.V. · 2016
- Descendant · 3 generations on · 0 of its ownK191072 7410 Ultrasound System (MyLabSigma)Esaote, S.p.A. · 2019
- Descendant · 3 generations on · 0 of its ownK190989 6400 Ultrasound System (MyLabX6, MyLabX7)Esaote, 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 deviceK141486 Mylabsix Ultrasound SystemEsaote Europe B.V. · 2014
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K070106 VV Fluoro 3D4 generations back · 2007
Most influential descendants
Showing 5 of 8 · See all- K142077MylabgammaEsaote, S.p.A. · 2014 · cites it directly5descendants
- K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A. · 2016 · 2 generations on4descendants
- K161168MyLabSix Ultrasound SystemEsaote Europe B.V. · 2016 · cites it directly1descendant
- K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A. · 2019 · 3 generations on0descendants
- K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A. · 2019 · 3 generations on0descendants
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) | K141486 | Mylabsix Ultrasound System | Esaote Europe B.V. | 2014 | — |
| +1 | K142077 | Mylabgamma | Esaote, S.p.A. | 2014 | 3 |
| +2 | K161359 | 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System | Esaote, S.p.A. | 2016 | 5 |
| +1 | K161168 | MyLabSix Ultrasound System | Esaote Europe B.V. | 2016 | — |
| +3 | K191072 | 7410 Ultrasound System (MyLabSigma) | Esaote, S.p.A. | 2019 | — |
| +3 | K190989 | 6400 Ultrasound System (MyLabX6, MyLabX7) | 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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 3 | 0 |
| 2018 | 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? (4)
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 2…m Page 00016 510(k) Summrnay ,MvLabSix Esaote Europe 807.92(a)(3) Predicate Device(s) Ki 111302, Kl132231 and Kl132466 MyLabSeven Esacte SpA K083882 Myl-ab~ive… | 2011 |
| * | K132231 | Mylabseven, MylabalphaSummary page 3…Technological Characteristics Esaote Europe By,. believes that the MyLabSix is substantial equivalent to Esaote's MyLabSeven product (KI 11302. K132231 and K132466) and Esaote's MyLabFive (K083882). *Clinical uses for which the MyLabSix is designed are equivalent to tho… | 2013 |
| * | K132466 | Mylabseven 6400, Mylabalpha 7400Summary page 3…Technological Characteristics Esaote Europe By,. believes that the MyLabSix is substantial equivalent to Esaote's MyLabSeven product (KI 11302. K132231 and K132466) and Esaote's MyLabFive (K083882). *Clinical uses for which the MyLabSix is designed are equivalent to those cleared f… | 2013 |
| * | K083882 | MylabfiveSummary page 2…x Esaote Europe 807.92(a)(3) Predicate Device(s) Ki 111302, Kl132231 and Kl132466 MyLabSeven Esacte SpA K083882 Myl-ab~ive Esacte Europe B. Additional substantial equivalence information is provide… | 2009 |
What descends from it? (8)
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)
No FDA recall names this device.
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 · 4 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 6 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, K142077 (Esaote, S.p.A., 2014) has gone furthest, with 5 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 MyLabSix ultrasound system 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, and Other: Urologic. The 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/K141486 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141486: Mylabsix 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/K141486
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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