510(k) · Cleared
Cleared6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
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 May 16, 2025 as substantially equivalent to K192157 (Esaote, S.p.A., 2019) and 1 other predicate after a 339-day review. Its family tree reaches back 22 generations to 1995. 7 of the 340 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- May 16, 2025
- Review
- 339 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 22 generations to K935595 (1995). 337 ancestors in all, the oldest K844472 (1985). 2 later devices descend from it, 2 citing it directly. 7 of the 340 devices in this family, counting this one, have a Class I recall.
- Root · 22 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 18 generations between
- 3 generations backK163082 6200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2017 · Recalled
- 2 generations backK173291 6440 Ultrasound SystemEsaote, S.p.A. · 2018
- 1 generation backK192157 6450 Ultrasound systemEsaote, S.p.A. · 2019
- This deviceK241671 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A. · 2025
- Descendant · cites it directly · 0 of its ownK253288 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A. · 2026
- Descendant · cites it directly · 0 of its ownK253310 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A. · 2025
Show all 22 generations
- Root · 22 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 21 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 20 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 19 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 18 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 17 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 16 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 15 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 14 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 13 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 12 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 11 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 10 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 9 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 8 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 7 generations backK120741 Voluson S6, Voluson S8GE Healthcare · 2012
- 6 generations backK122387 Voluson P6, Voluson P8GE Healthcare · 2012
- 5 generations backK131937 Voluson I/EGE Healthcare · 2013
- 4 generations backK151451 Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation · 2015 · Recalled
- 3 generations backK163082 6200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2017 · Recalled
- 2 generations backK173291 6440 Ultrasound SystemEsaote, S.p.A. · 2018
- 1 generation backK192157 6450 Ultrasound systemEsaote, S.p.A. · 2019
- This deviceK241671 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A. · 2025
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −21 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −20 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −19 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −18 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −17 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −16 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −15 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −14 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −13 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −12 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −11 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −10 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −9 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −8 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −7 | K120741 | Voluson S6, Voluson S8 | GE Healthcare | 2012 | — |
| −6 | K122387 | Voluson P6, Voluson P8 | GE Healthcare | 2012 | — |
| −5 | K131937 | Voluson I/E | GE Healthcare | 2013 | — |
| −4 | K151451 | Aplio 500/400/300 Diagnostic Ultrasound System V6.0 | Toshibamedical Systems Corporation | 2015 | 2 |
| −3 | K163082 | 6200 Ultrasound System and 6250 Ultrasound System | Esaote, S.p.A. | 2017 | 2 |
| −2 | K173291 | 6440 Ultrasound System | Esaote, S.p.A. | 2018 | — |
| −1 | K192157 | 6450 Ultrasound system | Esaote, S.p.A. | 2019 | — |
| 0 (this device) | K241671 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | Esaote, S.p.A. | 2025 | — |
| +1 | K253288 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | Esaote, S.p.A. | 2026 | — |
| +1 | K253310 | 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) | Esaote, S.p.A. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 11 | 0 |
| 1996 | 8 | 1 |
| 1997 | 14 | 0 |
| 1998 | 19 | 3 |
| 1999 | 23 | 0 |
| 2000 | 19 | 1 |
| 2001 | 21 | 0 |
| 2002 | 24 | 0 |
| 2003 | 26 | 0 |
| 2004 | 21 | 1 |
| 2005 | 23 | 0 |
| 2006 | 16 | 0 |
| 2007 | 9 | 1 |
| 2008 | 12 | 0 |
| 2009 | 9 | 0 |
| 2010 | 7 | 0 |
| 2011 | 12 | 0 |
| 2012 | 7 | 0 |
| 2013 | 7 | 0 |
| 2014 | 6 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2023 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 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.
7 devices in this family have 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? (2)
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 |
|---|---|---|---|
| * | K192157 | 6450 Ultrasound systemSummary page 6…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K192157 6450 MyLabX8 IYN K230179… | 2019 |
| * | K230179 | 6440 MyLabX90Summary page 6…Product Code K192157 6450 MyLabX8 IYN K230179 6440 MyLabX90 IYN Device D… | 2023 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (7 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 · 7 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
- K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 2004 · 7 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 8 generations back · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 8 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 8 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 8 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 8 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 7; all are on the web page.
What does this lineage say?
- The line of descent spans 30 years and passes through 7 companies; a new generation was cleared every 12 months on median.
- 87 of the 337 ancestors have a recall of any class; 7 have a Class I recall.
- Of its descendants, K253288 (Esaote, S.p.A., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K192157.
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. 2025, 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?
The multifunctional ultrasound scanner is used to collect, display and analyze ultrasound images during ultrasound imaging procedures in combination with supported echographic probes. Main application: Districts: Invasive access: Cardiac Cardiac Adult, Cardiac Pediatric Transesophageal Vascular Neonatal, Adult Cephalic, Vascular Not applicable General Imaging Abdominal, Breast, Musculoskeletal, Intraoperative (Abdominal), Neonatal, Pediatric, Small…
Read the full statement (177 words)
The multifunctional ultrasound scanner is used to collect, display and analyze ultrasound images
during ultrasound imaging procedures in combination with supported echographic probes.
Main application: Districts: Invasive access:
Cardiac Cardiac Adult, Cardiac Pediatric Transesophageal
Vascular Neonatal, Adult Cephalic, Vascular Not applicable
General Imaging Abdominal, Breast, Musculoskeletal, Intraoperative (Abdominal),
Neonatal, Pediatric, Small Organs Laparoscopic, Transrectal
(Testicles), Thyroid, Urological
Women Health OB/Fetal, Gynecology Transrectal, Transvaginal
Virtual Navigator option supports a radiological clinical ultrasound examination (first modality) by
providing additional image information from a second imaging modality. As second imaging modality
it is intended any image coming from CT, MR, US, PET, XA and NM.
The second modality provides additional security in assessing the morphology of the real time
ultrasound image.
The primary modes of operation are: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi
View (MView), Doppler (both Pulsed Wave (PW) and Continuous Wave (CW)), Color Flow Mapping
(CFM), Power Doppler, Tissue Velocity Mapping (TVM), Combined modes, Elastosonography,
3D/4D and CnTI.
The ultrasound scanner is suitable to be installed in professional healthcare facility environment and
is designed for ultrasound practitioners.
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/K241671 · printed Nov 4, 2026
Cite this page
510(k) Report. “K241671: 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K241671
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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