510(k) · Cleared
ClearedMylabtwice, Model 6200
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 Jun 25, 2010 as substantially equivalent to K051837 (Esaote, S.p.A., 2005) and 2 other predicates after an 81-day review. Its family tree reaches back 9 generations to 1993. 1 of the 114 devices in its family, counting itself, has a Class I recall. 46 later devices descend from it.
- Decided
- Jun 25, 2010
- Review
- 81 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K924432 (1993). 67 ancestors in all, the oldest K921148 (1992). 46 later devices descend from it, 3 citing it directly. 1 of the 114 devices in this family, counting this one, has a Class I recall.
- 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 backK060827 MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350…Esaote, S.p.A. · 2006
- 1 generation backK081386 Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A. · 2008 · Recalled
- This deviceK100931 Mylabtwice, Model 6200Esaote, S.p.A. · 2010
- Descendant · cites it directly · 34 of its ownK133905 6200 / 6250 Ultrasound SystemEsaote, S.p.A. · 2014
- Descendant · cites it directly · 22 of its ownK132466 Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A. · 2013
- Descendant · cites it directly · 22 of its ownK132231 Mylabseven, MylabalphaEsaote, S.p.A. · 2013
- 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
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 backK060827 MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350…Esaote, S.p.A. · 2006
- 1 generation backK081386 Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A. · 2008 · Recalled
- This deviceK100931 Mylabtwice, Model 6200Esaote, S.p.A. · 2010
Showing 5 of 46 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 46 · See all- K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A. · 2014 · cites it directly34descendants
- K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A. · 2013 · cites it directly22descendants
- K132231Mylabseven, MylabalphaEsaote, S.p.A. · 2013 · cites it directly22descendants
- K161999AixplorerSupersonic Imagine · 2016 · 2 generations on20descendants
- K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine · 2017 · 3 generations on19descendants
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 | K060827 | MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100 | Esaote, S.p.A. | 2006 | — |
| −1 | K081386 | Model 6150 (MYLAB70) and Model 6100 (MYLAB90) | Esaote, S.p.A. | 2008 | 2 |
| 0 (this device) | K100931 | Mylabtwice, Model 6200 | Esaote, S.p.A. | 2010 | — |
| +1 | K133905 | 6200 / 6250 Ultrasound System | Esaote, S.p.A. | 2014 | — |
| +1 | K132466 | Mylabseven 6400, Mylabalpha 7400 | Esaote, S.p.A. | 2013 | — |
| +1 | K132231 | Mylabseven, Mylabalpha | Esaote, S.p.A. | 2013 | — |
| +2 | K161999 | Aixplorer | Supersonic Imagine | 2016 | — |
| +3 | K171105 | AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems | Supersonic Imagine | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 5 | 0 |
| 1999 | 8 | 0 |
| 2000 | 6 | 0 |
| 2001 | 4 | 0 |
| 2002 | 9 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2016 | 5 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 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? (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 |
|---|---|---|---|
| * | K051837 | Mylab 90 Ultrasound Imaging System, Model 6100Summary page 2…x, and Phased array probes. The 61 00 system has been cleared by FDA via KO051837, K060827 and K081386. The modified 6100, with respect to the cleared version 6100 via K051837, K060827 and KOS81386, is due to the improvements of the system. These modifications, that do not affect the intended use or alte… | 2005 |
| * | K060827 | MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100Summary page 1…c pulsed echo imaging system 892.1560 Classification Number: 9OIYN; 901Y0 807.92(a)(3) Predicate Device(s) KO051837, K060827, 6100 Esaote, S.p.A. K08 1386 Esaote, Sp.A. 6200 Spe… | 2006 |
| * | K081386 | Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Summary page 1…901Y0 807.92(a)(3) Predicate Device(s) KO051837, K060827, 6100 Esaote, S.p.A. K08 1386 Esaote, Sp.A. 6200 Special 510O(k) Page 41 of 1017 Fswte1. S… | 2008 |
What descends from it? (46)
See all 463 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 17 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 13 of the 67 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.
- 4 other devices also cite its predicate K051837.
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. 2010, 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, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, lntraoperative (Abdominal), Laparoscopic and Other: Urologic. The 6200 system provides imaging for guidance of biopsy ahd imaging to assist…
Read the full statement (200 words)
Esaote's Model 6200 is a 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, lntraoperative (Abdominal), Laparoscopic and Other: Urologic. The 6200 system provides imaging for guidance of biopsy ahd 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 MyLab 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' foll owing application: Abdominal, Musculo-skeletal, Urologic, and Vascular.
The second modality image is not intended to be used as a standalone diagnostic image since it represeuits 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/K100931 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100931: Mylabtwice, Model 6200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100931
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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