510(k) · Cleared
ClearedMYLAB15/20 New Indications Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Esaote Europe B.V. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Aug 7, 2006 as substantially equivalent to K014168 (Biosound Esaote, Inc., 2002) and 2 other predicates after a 47-day review. Its family tree reaches back 8 generations to 1993. 28 later devices descend from it.
- Decided
- Aug 7, 2006
- Review
- 47 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K924432 (1993). 44 ancestors in all, the oldest K921148 (1992). 28 later devices descend from it, 1 citing it directly.
- 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 backK053154 MYLAB15/20 3D/4D Ultrasound Imaging SystemPie Medical · 2005
- This deviceK061755 MYLAB15/20 New Indications Ultrasound SystemEsaote Europe B.V. · 2006
- Descendant · cites it directly · 27 of its ownK070903 MYLAB40Esaote Europe B.V. · 2007
- Descendant · 2 generations on · 26 of its ownK083882 MylabfiveEsaote Europe B.V. · 2009
- Descendant · 3 generations on · 25 of its ownK101605 Mylabone Ultrasound SystemEsaote Europe B.V. · 2010
- Descendant · 4 generations on · 24 of its ownK111302 Mylabseven, MylabalphaEsaote, S.p.A. · 2011
- Descendant · 5 generations on · 22 of its ownK132466 Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A. · 2013
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K070903MYLAB40Esaote Europe B.V. · 2007 · cites it directly27descendants
- K083882MylabfiveEsaote Europe B.V. · 2009 · 2 generations on26descendants
- K101605Mylabone Ultrasound SystemEsaote Europe B.V. · 2010 · 3 generations on25descendants
- K111302Mylabseven, MylabalphaEsaote, S.p.A. · 2011 · 4 generations on24descendants
- K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A. · 2013 · 5 generations on22descendants
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 | K053154 | MYLAB15/20 3D/4D Ultrasound Imaging System | Pie Medical | 2005 | — |
| 0 (this device) | K061755 | MYLAB15/20 New Indications Ultrasound System | Esaote Europe B.V. | 2006 | — |
| +1 | K070903 | MYLAB40 | Esaote Europe B.V. | 2007 | — |
| +2 | K083882 | Mylabfive | Esaote Europe B.V. | 2009 | — |
| +3 | K101605 | Mylabone Ultrasound System | Esaote Europe B.V. | 2010 | — |
| +4 | K111302 | Mylabseven, Mylabalpha | Esaote, S.p.A. | 2011 | — |
| +5 | K132466 | Mylabseven 6400, Mylabalpha 7400 | 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 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 7 | 0 |
| 2000 | 6 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 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 IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K014168 | AU6 (Technos/Technos MP) Ultrasound Imaging System (Addition of 3D Imaging Mode and…Summary page 3…Esaote Europe BV Kok /1355 Comparison Chart for Substantial Equivalence General Esaote MyLab15/20 | Esaote Technos | Esaote MyLabl5/20 Characteristics K043588, K053154 K014168 Current 510(k) Applications Intraoperative: Abdominal No Yes Yes Other: Urological No Yes Yes 510(k) Summary MyLa… | 2002 |
| * | K043588 | Mylab 15 / Mylab 20, Model 2700Summary page 1…ng system 892.1560 Ultrasonic pulsed Doppler imaging system 832.1550 Classification Number: 90IYO 90IYN 807.92(a)(3) Predicate Device(s) KO014168 Technos Esaote, S.p.A. K043588 Myl ab15/20 Ultrasound System Pie Medical K053154 MyLab15/20 Just3D/4D Pie Medical Additional Substantial Equivélence Informatio… | 2005 |
| * | K053154 | MYLAB15/20 3D/4D Ultrasound Imaging SystemSummary page 1…ng system 832.1550 Classification Number: 90IYO 90IYN 807.92(a)(3) Predicate Device(s) KO014168 Technos Esaote, S.p.A. K043588 Myl ab15/20 Ultrasound System Pie Medical K053154 MyLab15/20 Just3D/4D Pie Medical Additional Substantial Equivélence Information is provided in the following substantial Equival… | 2005 |
What descends from it? (28)
See all 281 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070903 | MYLAB40 | 2007 | 27 |
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 4 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 44 ancestors have a recall of any class.
- Of its descendants, K070903 (Esaote Europe B.V., 2007) has gone furthest, with 27 descendants of its own.
- 6 other devices also cite its predicate K014168.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
Esaote’s MyLab15/MyLab20 is a compact console ultrasound system intended to be
used by a physician to perform general diagnostic ultrasound studies including Fetal,
Abdominal, Pediatric, Small organ, Neonatal Cephalic, Cardiac, Transrectal,
Transvaginal, Peripheral Vascular, Musculoskeletal (Conventional and Superficial),
Intraoperative: Abdominal, and Other: Urological.
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/K061755 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061755: MYLAB15/20 New Indications 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/K061755
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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