510(k) · Cleared
Cleared6200 / 6250 Ultrasound System
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 Apr 15, 2014 as substantially equivalent to K100931 (Esaote, S.p.A., 2010) and 3 other predicates after a 113-day review. Its family tree reaches back 16 generations to 1995. 1 of the 207 devices in its family, counting itself, has a Class I recall. 34 later devices descend from it.
- Decided
- Apr 15, 2014
- Review
- 113 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 16 generations to K935595 (1995). 172 ancestors in all, the oldest K863700 (1987). 34 later devices descend from it, 2 citing it directly. 1 of the 207 devices in this family, counting this one, has a Class I recall.
- Root · 16 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 12 generations between
- 3 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 2 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 1 generation backK123564 Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2012 · Recalled
- This deviceK133905 6200 / 6250 Ultrasound SystemEsaote, S.p.A. · 2014
- Descendant · cites it directly · 20 of its ownK161999 AixplorerSupersonic Imagine · 2016
- Descendant · 2 generations on · 19 of its ownK171105 AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine · 2017
- Descendant · 3 generations on · 18 of its ownK173021 Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine · 2018
- Descendant · 4 generations on · 16 of its ownK180572 AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30…Supersonic Imagine · 2018
- Descendant · cites it directly · 12 of its ownK153277 6200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2016
Show all 16 generations
- Root · 16 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 15 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 14 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 13 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 12 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 11 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 10 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 9 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 8 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 7 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 6 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 5 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 4 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 3 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 2 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 1 generation backK123564 Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2012 · Recalled
- This deviceK133905 6200 / 6250 Ultrasound SystemEsaote, S.p.A. · 2014
Showing 5 of 34 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 34 · See all- K161999AixplorerSupersonic Imagine · 2016 · cites it directly20descendants
- K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine · 2017 · 2 generations on19descendants
- K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine · 2018 · 3 generations on18descendants
- K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine · 2018 · 4 generations on16descendants
- K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2016 · cites it directly12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −15 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −14 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −13 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −12 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −11 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −10 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −9 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −8 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −7 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −6 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −5 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −4 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −3 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −2 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −1 | K123564 | Logiq E9 Diagnostic Ultrasound System | GE Healthcare | 2012 | 1 |
| 0 (this device) | K133905 | 6200 / 6250 Ultrasound System | Esaote, S.p.A. | 2014 | — |
| +1 | K161999 | Aixplorer | Supersonic Imagine | 2016 | — |
| +2 | K171105 | AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems | Supersonic Imagine | 2017 | — |
| +3 | K173021 | Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems | Supersonic Imagine | 2018 | — |
| +4 | K180572 | AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach… | Supersonic Imagine | 2018 | — |
| +1 | K153277 | 6200 Ultrasound System and 6250 Ultrasound System | Esaote, S.p.A. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 7 | 0 |
| 1996 | 1 | 0 |
| 1997 | 6 | 0 |
| 1998 | 8 | 0 |
| 1999 | 12 | 0 |
| 2000 | 10 | 0 |
| 2001 | 12 | 0 |
| 2002 | 14 | 0 |
| 2003 | 14 | 0 |
| 2004 | 17 | 0 |
| 2005 | 16 | 0 |
| 2006 | 10 | 0 |
| 2007 | 3 | 1 |
| 2008 | 6 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K100931 | Mylabtwice, Model 6200Summary page 2…ped in assessing the patient anatomy by displaying the image generated by the 2nd modality. 6200 models including Virtual Navigator software option have been cleared by k100931; 6250 models including Virtual Navigator software option have been cleared by k103152. Virtual Navigator has also been cleared fo… | 2010 |
| * | K103152 | 6250 Ultrasound SytemsSummary page 2…lity. 6200 models including Virtual Navigator software option have been cleared by k100931; 6250 models including Virtual Navigator software option have been cleared by k103152. Virtual Navigator has also been cleared for use with 6100 and 6150 models by k081386. The purpose of this submission isto intro… | 2011 |
| * | K081386 | Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Summary page 2…00931; 6250 models including Virtual Navigator software option have been cleared by k103152. Virtual Navigator has also been cleared for use with 6100 and 6150 models by k081386. The purpose of this submission isto introduce an upgrade to both Esaote 6200 and 6250 models to add additional software capabil… | 2008 |
| * | K123564 | Logiq E9 Diagnostic Ultrasound SystemSummary page 4…systems. " Clinical uses for which Virtual Navigator Upgrades are equivalent to those of General Electric Volume Navigation on the Logiq E9, cleared via k123564. " Esaote 6200, 6250 and General Electric (GE) Logiq ES ultrasound systems are equipped with a software option de… | 2012 |
What descends from it? (34)
See all 342 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 19 years and passes through 6 companies; a new generation was cleared every 12 months on median.
- 44 of the 172 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K161999 (Supersonic Imagine, 2016) has gone furthest, with 20 descendants of its own.
- 2 other devices also cite its predicate K100931.
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. 2014, 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 6200 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 6200 system provides imaging for guidance of biopsy and imaging to…
Read the full statement (303 words)
Esaote's Model 6200 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 6200 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.
Esaote's Model 6250 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, 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 software option for Esaote models 6200 and 6250 is intended to support a radiological clinical ultrasound examination (first modality) and follow percutaneous procedures or surgical operations providing additional image information from a second imaging modality (CT, MR, US and PET). The second modality provides additional security in assessing the morphology of the ultrasound image.
Virtual Navigator can be used in the following application: Abdominal, Gynecological, Musculo-skeletal, Obstetrics, Pediatric, Urologic, Small Organs, Peripheral Vascular and Transcranial for radiological examinations only.
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/K133905 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133905: 6200 / 6250 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/K133905
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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