510(k) · Cleared
ClearedMYLAB40
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Esaote Europe B.V. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Jul 2, 2007 as substantially equivalent to K043588 (Pie Medical, 2005) and 5 other predicates after a 91-day review. Its family tree reaches back 9 generations to 1993. 27 later devices descend from it.
- Decided
- Jul 2, 2007
- Review
- 91 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 9 generations to K924432 (1993). 61 ancestors in all, the oldest K921148 (1992). 27 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 5 generations between
- 3 generations backK043455 SA8000 SE Diagnostic Ultrasound SystemMedison Co., Ltd. · 2004
- 2 generations backK053154 MYLAB15/20 3D/4D Ultrasound Imaging SystemPie Medical · 2005
- 1 generation backK061755 MYLAB15/20 New Indications Ultrasound SystemEsaote Europe B.V. · 2006
- This deviceK070903 MYLAB40Esaote Europe B.V. · 2007
- Descendant · cites it directly · 26 of its ownK083882 MylabfiveEsaote Europe B.V. · 2009
- Descendant · 2 generations on · 25 of its ownK101605 Mylabone Ultrasound SystemEsaote Europe B.V. · 2010
- Descendant · 3 generations on · 24 of its ownK111302 Mylabseven, MylabalphaEsaote, S.p.A. · 2011
- Descendant · 4 generations on · 22 of its ownK132466 Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A. · 2013
- Descendant · 4 generations on · 22 of its ownK132231 Mylabseven, MylabalphaEsaote, S.p.A. · 2013
Show all 9 generations
- Root · 9 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 8 generations backK981510 Sonoace 6000/ Ultramark 400Medison America, Inc. · 1998
- 7 generations backK990970 Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also…Medison America, Inc. · 1999
- 6 generations backK002185 Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2000 · Recalled
- 5 generations backK013627 Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 2001
- 4 generations backK031552 Mycolor 202 Diagnostic Ultrasound System and TransducersMedison America, Inc. · 2003 · Recalled
- 3 generations backK043455 SA8000 SE Diagnostic Ultrasound SystemMedison Co., Ltd. · 2004
- 2 generations backK053154 MYLAB15/20 3D/4D Ultrasound Imaging SystemPie Medical · 2005
- 1 generation backK061755 MYLAB15/20 New Indications Ultrasound SystemEsaote Europe B.V. · 2006
- This deviceK070903 MYLAB40Esaote Europe B.V. · 2007
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K083882MylabfiveEsaote Europe B.V. · 2009 · cites it directly26descendants
- K101605Mylabone Ultrasound SystemEsaote Europe B.V. · 2010 · 2 generations on25descendants
- K111302Mylabseven, MylabalphaEsaote, S.p.A. · 2011 · 3 generations on24descendants
- K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A. · 2013 · 4 generations on22descendants
- K132231Mylabseven, MylabalphaEsaote, S.p.A. · 2013 · 4 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K924432 | Medison 1500 | Medison Co., Ltd. | 1993 | — |
| −8 | K981510 | Sonoace 6000/ Ultramark 400 | Medison America, Inc. | 1998 | — |
| −7 | K990970 | Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called… | Medison America, Inc. | 1999 | — |
| −6 | K002185 | Sonoace SA 9900 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | 1 |
| −5 | K013627 | Sonoace SA-8000 Diagnostic Ultrasound System | Medison America, Inc. | 2001 | — |
| −4 | K031552 | Mycolor 202 Diagnostic Ultrasound System and Transducers | Medison America, Inc. | 2003 | 5 |
| −3 | K043455 | SA8000 SE Diagnostic Ultrasound System | Medison Co., Ltd. | 2004 | — |
| −2 | K053154 | MYLAB15/20 3D/4D Ultrasound Imaging System | Pie Medical | 2005 | — |
| −1 | K061755 | MYLAB15/20 New Indications Ultrasound System | Esaote Europe B.V. | 2006 | — |
| 0 (this device) | K070903 | MYLAB40 | Esaote Europe B.V. | 2007 | — |
| +1 | K083882 | Mylabfive | Esaote Europe B.V. | 2009 | — |
| +2 | K101605 | Mylabone Ultrasound System | Esaote Europe B.V. | 2010 | — |
| +3 | K111302 | Mylabseven, Mylabalpha | Esaote, S.p.A. | 2011 | — |
| +4 | K132466 | Mylabseven 6400, Mylabalpha 7400 | Esaote, S.p.A. | 2013 | — |
| +4 | K132231 | Mylabseven, Mylabalpha | Esaote, S.p.A. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 6 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 8 | 0 |
| 2000 | 7 | 0 |
| 2001 | 1 | 0 |
| 2002 | 6 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 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.
Planning a device in ITX? 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 ITX device
- #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 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 |
|---|---|---|---|
| * | K043588 | Mylab 15 / Mylab 20, Model 2700Summary page 2…10(k) Summary MyLab40 Esaote Europe 807.92(a)(3) Predicate Device(s) Pie Medical MyLab20 K043588 Pie Medical MyLab2O K053154 Esaote Europe MyLab2O… | 2005 |
| * | K053154 | MYLAB15/20 3D/4D Ultrasound Imaging SystemSummary page 2…Predicate Device(s) Pie Medical MyLab20 K043588 Pie Medical MyLab2O K053154 Esaote Europe MyLab2O K06 1755 Esaote S.p.A. MyLab3O… | 2005 |
| * | K061755 | MYLAB15/20 New Indications Ultrasound SystemSummary page 2…K043588 Pie Medical MyLab2O K053154 Esaote Europe MyLab2O K06 1755 Esaote S.p.A. MyLab3O K040596 Esaote S p.A. MyLab30… | 2006 |
| * | K040596 | Ultrasound Imaging System, Model 7300Summary page 2…K053154 Esaote Europe MyLab2O K06 1755 Esaote S.p.A. MyLab3O K040596 Esaote S p.A. MyLab30 K052805 Esaote S.pA. MyLab3O… | 2004 |
| * | K052805 | MYLAB30, 50 and 70 Systems Upgrade, Models 7300, 7350, 6150Summary page 2…K06 1755 Esaote S.p.A. MyLab3O K040596 Esaote S p.A. MyLab30 K052805 Esaote S.pA. MyLab3O K060827 Additional Substantial Equivalence Information is pr… | 2005 |
| * | K060827 | MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100Summary page 2…K040596 Esaote S p.A. MyLab30 K052805 Esaote S.pA. MyLab3O K060827 Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table. 807.92… | 2006 |
What descends from it? (27)
See all 271 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083882 | Mylabfive | 2009 | 26 |
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 14 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 9 of the 61 ancestors have a recall of any class.
- Of its descendants, K083882 (Esaote Europe B.V., 2009) has gone furthest, with 26 descendants of its own.
- 2 other devices also cite its predicate K043588.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 2025
MAUDE reports naming product code ITX, 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 | 10 | 26 | 0 | 16 |
| 2008 | 12 | 73 | 4 | 39 |
| 2009 | 17 | 28 | 4 | 23 |
| 2010 | 10 | 42 | 4 | 30 |
| 2011 | 10 | 16 | 1 | 34 |
| 2012 | 7 | 25 | 1 | 29 |
| 2013 | 3 | 105 | 0 | 38 |
| 2014 | 4 | 41 | 1 | 43 |
| 2015 | 1 | — | 5 | 183 |
| 2016 | 4 | 151 | 0 | 269 |
| 2017 | 6 | 110 | 1 | 412 |
| 2018 | 2 | — | 15 | 130 |
| 2019 | 1 | — | 0 | 119 |
| 2020 | 3 | 120 | 3 | 116 |
| 2021 | 3 | 139 | 10 (10) | 146 |
| 2022 | 2 | — | 6 | 87 |
| 2023 | 6 | 213 | 1 | 138 |
| 2024 | 3 | 81 | 1 | 988 |
| 2025 | 4 | 126 | 2 | 571 |
| 2026 | 6 | 158 | 0 | — |
What is it indicated for?
Esaote's MyLab4O is a compact console 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.
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/K070903 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070903: MYLAB40.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070903
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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