510(k) · Cleared
ClearedMYLAB15/20 3D/4D Ultrasound Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pie Medical · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Dec 16, 2005 as substantially equivalent to K014168 (Biosound Esaote, Inc., 2002) and 3 other predicates after a 32-day review. Its family tree reaches back 7 generations to 1993. 29 later devices descend from it.
- Decided
- Dec 16, 2005
- Review
- 32 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K924432 (1993). 43 ancestors in all, the oldest K921148 (1992). 29 later devices descend from it, 2 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 deviceK053154 MYLAB15/20 3D/4D Ultrasound Imaging SystemPie Medical · 2005
- Descendant · cites it directly · 28 of its ownK061755 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
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K061755MYLAB15/20 New Indications Ultrasound SystemEsaote Europe B.V. · 2006 · cites it directly28descendants
- 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
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) | K053154 | MYLAB15/20 3D/4D Ultrasound Imaging System | Pie Medical | 2005 | — |
| +1 | 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 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 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 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? (4)
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 1…er imaging system 832.1550 Classification Number: 901YO 901YN 807.92(a)(3) Predicate Device(s) K014168 Technos Esaote, S.p.A. K043588 MyLabl5/20 Ultrasound Systcm Pie… | 2002 |
| * | K043588 | Mylab 15 / Mylab 20, Model 2700Summary page 1…901YN 807.92(a)(3) Predicate Device(s) K014168 Technos Esaote, S.p.A. K043588 MyLabl5/20 Ultrasound Systcm Pie Medical K043455 8000Live Mcdiso… | 2005 |
| * | K043455 | SA8000 SE Diagnostic Ultrasound SystemSummary page 1…Predicate Device(s) K014168 Technos Esaote, S.p.A. K043588 MyLabl5/20 Ultrasound Systcm Pie Medical K043455 8000Live Mcdison K040060 G50 Siemens A… | 2004 |
| * | K040060 | Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSummary page 1…Esaote, S.p.A. K043588 MyLabl5/20 Ultrasound Systcm Pie Medical K043455 8000Live Mcdison K040060 G50 Siemens Additional Substantial Equivalence Information is provided in the fol… | 2004 |
What descends from it? (29)
See all 292 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 12 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 43 ancestors have a recall of any class.
- Of its descendants, K061755 (Esaote Europe B.V., 2006) has gone furthest, with 28 descendants of its own.
- 6 other devices also cite its predicate K014168.
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?
The following table provides the intended clinical use for the MyLab15/20:
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/K053154 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053154: MYLAB15/20 3D/4D Ultrasound Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053154
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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