510(k) · Cleared
ClearedMYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100
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 May 19, 2006 as substantially equivalent to K040596 (Esaote, S.p.A., 2004) and 5 other predicates after a 53-day review. Its family tree reaches back 7 generations to 1993. 62 later devices descend from it.
- Decided
- May 19, 2006
- Review
- 53 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 7 generations to K924432 (1993). 46 ancestors in all, the oldest K921148 (1992). 62 later devices descend from it, 9 citing it directly.
- Root · 7 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 6 generations backK981510 Sonoace 6000/ Ultramark 400Medison America, Inc. · 1998
- 5 generations backK990970 Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also…Medison America, Inc. · 1999
- 4 generations backK002185 Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2000 · Recalled
- 3 generations backK013627 Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 2001
- 2 generations backK031552 Mycolor 202 Diagnostic Ultrasound System and TransducersMedison America, Inc. · 2003 · Recalled
- 1 generation backK043455 SA8000 SE Diagnostic Ultrasound SystemMedison Co., Ltd. · 2004
- This deviceK060827 MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350…Esaote, S.p.A. · 2006
- Descendant · cites it directly · 57 of its ownK081794 Model 7340 Ultrasound SystemEsaote, S.p.A. · 2008
- Descendant · cites it directly · 53 of its ownK081386 Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A. · 2008 · Recalled
- 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
Showing 5 of 62 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 62 · See all- K081794Model 7340 Ultrasound SystemEsaote, S.p.A. · 2008 · cites it directly57descendants
- K081386Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A. · 2008 · cites it directly53descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K924432 | Medison 1500 | Medison Co., Ltd. | 1993 | — |
| −6 | K981510 | Sonoace 6000/ Ultramark 400 | Medison America, Inc. | 1998 | — |
| −5 | K990970 | Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called… | Medison America, Inc. | 1999 | — |
| −4 | K002185 | Sonoace SA 9900 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | 1 |
| −3 | K013627 | Sonoace SA-8000 Diagnostic Ultrasound System | Medison America, Inc. | 2001 | — |
| −2 | K031552 | Mycolor 202 Diagnostic Ultrasound System and Transducers | Medison America, Inc. | 2003 | 5 |
| −1 | K043455 | SA8000 SE Diagnostic Ultrasound System | Medison Co., Ltd. | 2004 | — |
| 0 (this device) | K060827 | MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100 | Esaote, S.p.A. | 2006 | — |
| +1 | K081794 | Model 7340 Ultrasound System | Esaote, S.p.A. | 2008 | — |
| +1 | K081386 | Model 6150 (MYLAB70) and Model 6100 (MYLAB90) | Esaote, S.p.A. | 2008 | 2 |
| +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 | — |
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 | 4 | 0 |
| 1999 | 7 | 0 |
| 2000 | 5 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 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.
Planning a device in IYN? 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 |
|---|---|---|---|
| * | K040596 | Ultrasound Imaging System, Model 7300Summary page 1…asonic pulsed echo imaging system 892.1560 Classification Number: 90IYN; 901YO 807.92(aXl3) Predicate Device(s) K040596 7300 (MyLab3O) Esaote, S.p.A. K050326 7350 (MyLab5O)… | 2004 |
| * | K050326 | 7350 Ultrasound Imaging System, Model 7350Summary page 1…901YO 807.92(aXl3) Predicate Device(s) K040596 7300 (MyLab3O) Esaote, S.p.A. K050326 7350 (MyLab5O) Esaote, S.p.A. K051308 6150 (MyLab7O)… | 2005 |
| * | K051308 | Mylab 70 Ultrasound Imaging SystemSummary page 1…K040596 7300 (MyLab3O) Esaote, S.p.A. K050326 7350 (MyLab5O) Esaote, S.p.A. K051308 6150 (MyLab7O) Esaote, S.p.A. K051837 6100 (MyLab90)… | 2005 |
| * | K051837 | Mylab 90 Ultrasound Imaging System, Model 6100Summary page 1…K050326 7350 (MyLab5O) Esaote, S.p.A. K051308 6150 (MyLab7O) Esaote, S.p.A. K051837 6100 (MyLab90) Esaote, S.p.A. K043455 8000Live… | 2005 |
| * | K043455 | SA8000 SE Diagnostic Ultrasound SystemSummary page 1…K051308 6150 (MyLab7O) Esaote, S.p.A. K051837 6100 (MyLab90) Esaote, S.p.A. K043455 8000Live Medison K022567 Sequoia Signature II S… | 2004 |
| * | K022567 | Sequoia Signature II Diagnostic Ultrasound SystemSummary page 1…K051837 6100 (MyLab90) Esaote, S.p.A. K043455 8000Live Medison K022567 Sequoia Signature II Siemens… | 2002 |
What descends from it? (62)
See all 629 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081794 | Model 7340 Ultrasound System | 2008 | 57 |
| K081386 | Model 6150 (MYLAB70) and Model 6100 (MYLAB90) | 2008 | 53 |
| K091009 | MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60… | 2009 | 51 |
| K100931 | Mylabtwice, Model 6200 | 2010 | 46 |
| K103152 | 6250 Ultrasound Sytems | 2011 | 35 |
| K070903 | MYLAB40 | 2007 | 27 |
| K111302 | Mylabseven, Mylabalpha | 2011 | 24 |
| K142008 | Mylabseven, Mylabalpha | 2014 | 19 |
| K071996 | MYLAB30, Model 7300 | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 8 of the 46 ancestors have a recall of any class.
- Of its descendants, K081794 (Esaote, S.p.A., 2008) has gone furthest, with 57 descendants of its own.
- 5 other devices also cite its predicate K040596.
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.
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 7300 (MyLab3O) is a compact ultrasound system 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. Esaote's Model 7350 (MyLab5O) is a mainframe ultrasound system used to perform…
Read the full statement (165 words)
Esaote's Model 7300 (MyLab3O) is a compact ultrasound system 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.
Esaote's Model 7350 (MyLab5O) is a mainframe ultrasound system 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.
Esaote's Model 6150 (MyLab7O) is a mainframe ultrasound system 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.
Esaote's Model 6100 (MyLab9O) is a mainframe ultrasound system used to perform
diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral
Vascular, Neonatal Cephalic, Small organ, Musculoskeletal (Conventional and
Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Adult Cephalic,
Laparoscopic, Intraoperative: Abdominal, and Other Urologic.
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/K060827 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060827: MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060827
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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