510(k) · Cleared
Recalled · Class II · 2018Model 6150 (MYLAB70) and Model 6100 (MYLAB90)
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 25, 2008 as substantially equivalent to K070106 (Brainlab AG, 2007) and 8 other predicates after a 129-day review. Its family tree reaches back 8 generations to 1993. 1 of the 120 devices in its family, counting itself, has a Class I recall. 53 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 25, 2008
- Review
- 129 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 2
- Predicates
- 9
Its longest line of descent runs back 8 generations to K924432 (1993). 66 ancestors in all, the oldest K921148 (1992). 53 later devices descend from it, 5 citing it directly. 1 of the 120 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 7 generations backK981510 Sonoace 6000/ Ultramark 400Medison America, Inc. · 1998
- 6 generations backK990970 Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also…Medison America, Inc. · 1999
- 5 generations backK002185 Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2000 · Recalled
- 4 generations backK013627 Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 2001
- 3 generations backK031552 Mycolor 202 Diagnostic Ultrasound System and TransducersMedison America, Inc. · 2003 · Recalled
- 2 generations backK043455 SA8000 SE Diagnostic Ultrasound SystemMedison Co., Ltd. · 2004
- 1 generation backK060827 MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350…Esaote, S.p.A. · 2006
- This deviceK081386 Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A. · 2008
- Descendant · cites it directly · 51 of its ownK091009 MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY…Esaote, S.p.A. · 2009
- Descendant · cites it directly · 46 of its ownK100931 Mylabtwice, Model 6200Esaote, S.p.A. · 2010
- Descendant · cites it directly · 35 of its ownK103152 6250 Ultrasound SytemsEsaote, S.p.A. · 2011
- Descendant · cites it directly · 34 of its ownK133905 6200 / 6250 Ultrasound SystemEsaote, S.p.A. · 2014
- Descendant · 2 generations on · 25 of its ownK110688 MylabgoldEsaote · 2011 · Recalled
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K070106 VV Fluoro 3Ddirect predicate · 2007
Most influential descendants
Showing 5 of 53 · See all- K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A. · 2009 · cites it directly51descendants
- K100931Mylabtwice, Model 6200Esaote, S.p.A. · 2010 · cites it directly46descendants
- K1031526250 Ultrasound SytemsEsaote, S.p.A. · 2011 · cites it directly35descendants
- K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A. · 2014 · cites it directly34descendants
- K110688MylabgoldEsaote · 2011 · 2 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K924432 | Medison 1500 | Medison Co., Ltd. | 1993 | — |
| −7 | K981510 | Sonoace 6000/ Ultramark 400 | Medison America, Inc. | 1998 | — |
| −6 | K990970 | Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called… | Medison America, Inc. | 1999 | — |
| −5 | K002185 | Sonoace SA 9900 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | 1 |
| −4 | K013627 | Sonoace SA-8000 Diagnostic Ultrasound System | Medison America, Inc. | 2001 | — |
| −3 | K031552 | Mycolor 202 Diagnostic Ultrasound System and Transducers | Medison America, Inc. | 2003 | 5 |
| −2 | K043455 | SA8000 SE Diagnostic Ultrasound System | Medison Co., Ltd. | 2004 | — |
| −1 | K060827 | MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100 | Esaote, S.p.A. | 2006 | — |
| 0 (this device) | K081386 | Model 6150 (MYLAB70) and Model 6100 (MYLAB90) | Esaote, S.p.A. | 2008 | — |
| +1 | K091009 | MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY… | Esaote, S.p.A. | 2009 | — |
| +1 | K100931 | Mylabtwice, Model 6200 | Esaote, S.p.A. | 2010 | — |
| +1 | K103152 | 6250 Ultrasound Sytems | Esaote, S.p.A. | 2011 | — |
| +1 | K133905 | 6200 / 6250 Ultrasound System | Esaote, S.p.A. | 2014 | — |
| +2 | K110688 | Mylabgold | Esaote | 2011 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 5 | 0 |
| 1999 | 8 | 0 |
| 2000 | 6 | 0 |
| 2001 | 4 | 0 |
| 2002 | 9 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2016 | 5 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 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? (9)
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 |
|---|---|---|---|
| * | K070106 | VV Fluoro 3DSummary page 1…Ultrasonic pulsed echo imaging system 892.1560 Classification Number: 90IYN; 901YO 8 07.92(a)(3) Predicate Device(s) K070106, K062086, K042391, K012564, and K042512K042512 ~~~BrainL~ab IGSonic K05130… | 2007 |
| * | K062086 | NavivisionSummary page 1…onic pulsed echo imaging system 892.1560 Classification Number: 90IYN; 901YO 8 07.92(a)(3) Predicate Device(s) K070106, K062086, K042391, K012564, and K042512K042512 ~~~BrainL~ab IGSonic K051308… | 2006 |
| * | K042391 | Kolibri Image Guided Surgery SystemSummary page 1…d echo imaging system 892.1560 Classification Number: 90IYN; 901YO 8 07.92(a)(3) Predicate Device(s) K070106, K062086, K042391, K012564, and K042512K042512 ~~~BrainL~ab IGSonic K051308… | 2004 |
| * | K012564 | Modification to: Vectorvision Frameless Biopsy SystemSummary page 1…aging system 892.1560 Classification Number: 90IYN; 901YO 8 07.92(a)(3) Predicate Device(s) K070106, K062086, K042391, K012564, and K042512K042512 ~~~BrainL~ab IGSonic K051308 My… | 2001 |
| * | K042512 | Vectorvision AclSummary page 1…0 Classification Number: 90IYN; 901YO 8 07.92(a)(3) Predicate Device(s) K070106, K062086, K042391, K012564, and K042512K042512 ~~~BrainL~ab IGSonic K051308 MyLab7O… | 2005 |
| * | K051308 | Mylab 70 Ultrasound Imaging SystemSummary page 1…Predicate Device(s) K070106, K062086, K042391, K012564, and K042512K042512 ~~~BrainL~ab IGSonic K051308 MyLab7O Esaote, S.p.A. K051837 MyLab9O… | 2005 |
| * | K051837 | Mylab 90 Ultrasound Imaging System, Model 6100Summary page 1…K042512K042512 ~~~BrainL~ab IGSonic K051308 MyLab7O Esaote, S.p.A. K051837 MyLab9O Esaote, S.p.A. K060827 MyLab 70, 90… | 2005 |
| * | K060827 | MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100Summary page 1…K051308 MyLab7O Esaote, S.p.A. K051837 MyLab9O Esaote, S.p.A. K060827 MyLab 70, 90 Esaote, S.p.A. K013722 RVS… | 2006 |
| * | K013722 | Modification to: Eub-8500 Diagnostic Ultrasound ScannerSummary page 1…K051837 MyLab9O Esaote, S.p.A. K060827 MyLab 70, 90 Esaote, S.p.A. K013722 RVS Hitachi 5 10(k) Summary MyLab70, 90 Systems Esaote. S.p.A.… | 2002 |
What descends from it? (53)
See all 535 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 |
|---|---|---|---|---|
| Jan 3, 2018 | Class II | Z-1138-2018 | Software design | The ultrasound system used in certain settings may result in overheating of the ultrasound probe head. |
| Jan 3, 2018 | Class II | Z-1137-2018 | Software design | The ultrasound system used in certain settings may result in overheating of the ultrasound probe head. |
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 · Direct predicate · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 12 of the 66 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K091009 (Esaote, S.p.A., 2009) has gone furthest, with 51 descendants of its own.
- 9 other devices also cite its predicate K070106.
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. 2008, 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 6150 (MyLab7O) and Model 6100 (MyLab9O) are mainframe ultrasound systems used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative: Abdominal, and Other: Urologic. Additionally, the MyLab9O is indicated for Laparoscopic…
Read the full statement (177 words)
Esaote's Model 6150 (MyLab7O) and Model 6100 (MyLab9O) are mainframe ultrasound systems used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative: Abdominal, and Other: Urologic. Additionally, the MyLab9O is indicated for Laparoscopic use.
The Virtual Navigator is a MyLab optional license that provides additional image information from a second modality like CT or MR, during a clinical ultrasound session. The second modality provides additional security in assessing the morphology of the ultrasound image.
Virtual Navigator can be used in the following application: Abdominal, Musculo-skeletal, Urologic, and Vascular.
The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always been seen as an additional source of information.
The Virtual Navigator tracking system should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081386 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081386: Model 6150 (MYLAB70) and Model 6100 (MYLAB90).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081386
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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