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 Sep 2, 2016 as substantially equivalent to K141486 (Esaote Europe B.V., 2014) and 6 other predicates after a 129-day review. Its family tree reaches back 15 generations to 1995. 1 of the 163 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Sep 2, 2016
- Review
- 129 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 15 generations to K935595 (1995). 161 ancestors in all, the oldest K891689 (1989). 1 later device descends from it, 1 citing it directly. 1 of the 163 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 11 generations between
- 3 generations backK110688 MylabgoldEsaote · 2011 · Recalled
- 2 generations backK132231 Mylabseven, MylabalphaEsaote, S.p.A. · 2013
- 1 generation backK141486 Mylabsix Ultrasound SystemEsaote Europe B.V. · 2014
- This deviceK161168 MyLabSix Ultrasound SystemEsaote Europe B.V. · 2016
- Descendant · cites it directly · 0 of its ownK183191 6420 Ultrasound SystemEsaote, S.p.A. · 2018
Show all 15 generations
- Root · 15 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 14 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 13 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 12 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 11 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 10 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 9 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 8 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 7 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 6 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 5 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 4 generations backK091009 MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY…Esaote, S.p.A. · 2009
- 3 generations backK110688 MylabgoldEsaote · 2011 · Recalled
- 2 generations backK132231 Mylabseven, MylabalphaEsaote, S.p.A. · 2013
- 1 generation backK141486 Mylabsix Ultrasound SystemEsaote Europe B.V. · 2014
- This deviceK161168 MyLabSix Ultrasound SystemEsaote Europe B.V. · 2016
Class I recalls in this family
- K070106 VV Fluoro 3D3 generations back · 2007
Most influential descendants
Showing 1 of 1 · See all- K1831916420 Ultrasound SystemEsaote, S.p.A. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −14 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −13 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −12 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −11 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −10 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −9 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −8 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −7 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −6 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −5 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −4 | K091009 | MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY… | Esaote, S.p.A. | 2009 | — |
| −3 | K110688 | Mylabgold | Esaote | 2011 | 1 |
| −2 | K132231 | Mylabseven, Mylabalpha | Esaote, S.p.A. | 2013 | — |
| −1 | K141486 | Mylabsix Ultrasound System | Esaote Europe B.V. | 2014 | — |
| 0 (this device) | K161168 | MyLabSix Ultrasound System | Esaote Europe B.V. | 2016 | — |
| +1 | K183191 | 6420 Ultrasound System | Esaote, S.p.A. | 2018 | — |
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 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (7)
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 |
|---|---|---|---|
| * | K141486 | Mylabsix Ultrasound SystemSummary page 4…) P P P P P P P P: 5 N: 7 6420 is already cleared via K141486 and to be cleared with this submission N: New indication; P: Previously cleared by FDA; E:Added under Appendix E [1] Small Orga… | 2014 |
| * | K111302 | Mylabseven, MylabalphaSummary page 33…its predicate devices. The MyLabSix Upgrade is substantially equivalent to Esaote Europe’s MyLabSix already cleared via K141486, Esaote’s MyLabSeven already cleared via K111302, K132231, K132466 and K142008, Esaote Europe’s MyLabOne already cleared via K101605 and to SonoSite Edge already cleared via K113… | 2011 |
| * | K132231 | Mylabseven, MylabalphaSummary page 33…icate devices. The MyLabSix Upgrade is substantially equivalent to Esaote Europe’s MyLabSix already cleared via K141486, Esaote’s MyLabSeven already cleared via K111302, K132231, K132466 and K142008, Esaote Europe’s MyLabOne already cleared via K101605 and to SonoSite Edge already cleared via K113156.… | 2013 |
| * | K132466 | Mylabseven 6400, Mylabalpha 7400Summary page 33…ices. The MyLabSix Upgrade is substantially equivalent to Esaote Europe’s MyLabSix already cleared via K141486, Esaote’s MyLabSeven already cleared via K111302, K132231, K132466 and K142008, Esaote Europe’s MyLabOne already cleared via K101605 and to SonoSite Edge already cleared via K113156. • C… | 2013 |
| * | K142008 | Mylabseven, MylabalphaSummary page 32…Device Owner Primary K141486 6420 – MyLabSix Esaote Europe B.V. Reference K142008 6400 – MyLabSeven Esaote S.p.A. Reference K101605 8100 – MyLabOne Es… | 2014 |
| * | K101605 | Mylabone Ultrasound SystemSummary page 7…P P P P P P E: 5 Other (Urological) The SL3116 probe is already cleared via K101605 and added under Appendix E N: New indication; P: Previously cleared by FDA; E:Added under Appendix E [1] Small Organs includes Br… | 2010 |
| * | K113156 | Sonosite Edge Ultrasound SystemSummary page 32…6400 – MyLabSeven Esaote S.p.A. Reference K101605 8100 – MyLabOne Esaote Europe B.V. Reference K113156 SonoSite Edge Fujifilm SonoSite, Inc. Additional substantial equivalence information is provided in the su… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183191 | 6420 Ultrasound System | 2018 | 0 |
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 · 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.
- 38 of the 161 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K183191 (Esaote, S.p.A., 2018) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K141486.
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 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, Laparoscopic 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/K161168 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161168: 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/K161168
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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