510(k) · Cleared
Cleared6250 Ultrasound Sytems
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 Jan 7, 2011 as substantially equivalent to K051308 (Esaote, S.p.A., 2005) and 4 other predicates after a 73-day review. Its family tree reaches back 12 generations to 1995. 1 of the 153 devices in its family, counting itself, has a Class I recall. 35 later devices descend from it.
- Decided
- Jan 7, 2011
- Review
- 73 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 12 generations to K935595 (1995). 117 ancestors in all, the oldest K891689 (1989). 35 later devices descend from it, 1 citing it directly. 1 of the 153 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 8 generations between
- 3 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 2 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 1 generation backK091009 MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY…Esaote, S.p.A. · 2009
- This deviceK103152 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 · 20 of its ownK161999 AixplorerSupersonic Imagine · 2016
- Descendant · 3 generations on · 19 of its ownK171105 AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine · 2017
- Descendant · 4 generations on · 18 of its ownK173021 Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine · 2018
- Descendant · 5 generations on · 16 of its ownK180572 AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30…Supersonic Imagine · 2018
Show all 12 generations
- Root · 12 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 11 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 10 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 9 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 8 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 7 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 6 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 5 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 4 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 3 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 2 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 1 generation backK091009 MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY…Esaote, S.p.A. · 2009
- This deviceK103152 6250 Ultrasound SytemsEsaote, S.p.A. · 2011
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K070106 VV Fluoro 3D2 generations back · 2007
Most influential descendants
Showing 5 of 35 · See all- K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A. · 2014 · cites it directly34descendants
- K161999AixplorerSupersonic Imagine · 2016 · 2 generations on20descendants
- K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine · 2017 · 3 generations on19descendants
- K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine · 2018 · 4 generations on18descendants
- K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine · 2018 · 5 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −11 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −10 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −9 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −8 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −7 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −6 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −5 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −4 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −3 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −2 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −1 | K091009 | MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY… | Esaote, S.p.A. | 2009 | — |
| 0 (this device) | K103152 | 6250 Ultrasound Sytems | Esaote, S.p.A. | 2011 | — |
| +1 | K133905 | 6200 / 6250 Ultrasound System | Esaote, S.p.A. | 2014 | — |
| +2 | K161999 | Aixplorer | Supersonic Imagine | 2016 | — |
| +3 | K171105 | AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems | Supersonic Imagine | 2017 | — |
| +4 | K173021 | Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems | Supersonic Imagine | 2018 | — |
| +5 | K180572 | AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach… | Supersonic Imagine | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 6 | 0 |
| 1997 | 5 | 0 |
| 1998 | 7 | 0 |
| 1999 | 11 | 0 |
| 2000 | 9 | 0 |
| 2001 | 8 | 0 |
| 2002 | 11 | 0 |
| 2003 | 8 | 0 |
| 2004 | 14 | 0 |
| 2005 | 10 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 1 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 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? (5)
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 |
|---|---|---|---|
| * | K051308 | Mylab 70 Ultrasound Imaging SystemSummary page 1…trasonic pulsed echo imaging system 892.1560 Classification Number: 9OIYN; 901Y0; 90ITX 807.92(a)(3) Predicate Device(s) K051308, K052805, *K060827, K08 1386 and 6150 Esaote, S.p.A. K09 1009 Esaote, Sp.A.… | 2005 |
| * | K052805 | MYLAB30, 50 and 70 Systems Upgrade, Models 7300, 7350, 6150Summary page 1…pulsed echo imaging system 892.1560 Classification Number: 9OIYN; 901Y0; 90ITX 807.92(a)(3) Predicate Device(s) K051308, K052805, *K060827, K08 1386 and 6150 Esaote, S.p.A. K09 1009 Esaote, Sp.A.… | 2005 |
| * | K060827 | MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100Summary page 1…imaging system 892.1560 Classification Number: 9OIYN; 901Y0; 90ITX 807.92(a)(3) Predicate Device(s) K051308, K052805, *K060827, K08 1386 and 6150 Esaote, S.p.A. K09 1009 Esaote, Sp.A.… | 2006 |
| * | K081386 | Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Summary page 1…system 892.1560 Classification Number: 9OIYN; 901Y0; 90ITX 807.92(a)(3) Predicate Device(s) K051308, K052805, *K060827, K08 1386 and 6150 Esaote, S.p.A. K09 1009 Esaote, Sp.A. 6250 S… | 2008 |
| * | K091009 | MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Summary page 1…(3) Predicate Device(s) K051308, K052805, *K060827, K08 1386 and 6150 Esaote, S.p.A. K09 1009 Esaote, Sp.A. 6250 Special 510(k) Page 11 of 1219 Esaote, Sp.… | 2009 |
What descends from it? (35)
See all 351 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133905 | 6200 / 6250 Ultrasound System | 2014 | 34 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · 2 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 28 of the 117 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K133905 (Esaote, S.p.A., 2014) has gone furthest, with 34 descendants of its own.
- 5 other devices also cite its predicate K051308.
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. 2011, 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 6250 isa 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), Laparoscopic and Other: Urologic. The 6250 system provides imaging for guidance of biopsy and imaging to assist in…
Read the full statement (198 words)
Esaote's Model 6250 isa 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), Laparoscopic and Other: Urologic. The 6250 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
The Virtual Navigator is a Mytab 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K103152 · printed Nov 3, 2026
Cite this page
510(k) Report. “K103152: 6250 Ultrasound Sytems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K103152
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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