510(k) · Cleared
Cleared6430 MyLabX75, 6430 MyLab XPro75
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 Sep 16, 2021 as substantially equivalent to K192157 (Esaote, S.p.A., 2019) after an 80-day review. Its family tree reaches back 22 generations to 1995. 7 of the 337 devices in its family, counting itself, have a Class I recall.
- Decided
- Sep 16, 2021
- Review
- 80 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 22 generations to K935595 (1995). 336 ancestors in all, the oldest K844472 (1985). No later device cites it as a predicate yet. 7 of the 337 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 deviceK212021 6430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A. · 2021
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 deviceK212021 6430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A. · 2021
Class I recalls in this family
View 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) | K212021 | 6430 MyLabX75, 6430 MyLab XPro75 | Esaote, S.p.A. | 2021 | — |
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 |
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? (1)
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 5…Predicate Device(s) Predicate 510(k) Device Owner Primary K192157 6450 – MyLabX8 Esaote S.p.A. This predicate has not been subject to a design-related recall 8… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 7 companies; a new generation was cleared every 12 months on median.
- 86 of the 336 ancestors have a recall of any class; 7 have a Class I recall.
- 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. 2021, 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 MyLabX75 Family is used to collect, display, and analyze ultrasound images during ultrasound imaging procedures in combination with supported echographic probes -Cardiac [Adult and Pediatric] -Vascular [Neonatal, Adult Cephalic, Vascular generic] -General Imaging [Abdominal, Breast, Musculo-skeletal, Neonatal, Pediatric, Small Organs (Testicles), Thyroid, Urological ] with invasive access Intraoperative (Abdominal)…
Read the full statement (147 words)
The multifunctional ultrasound scanner MyLabX75 Family is used to collect,
display, and analyze ultrasound images during ultrasound imaging procedures
in combination with supported echographic probes
-Cardiac [Adult and Pediatric]
-Vascular [Neonatal, Adult Cephalic, Vascular generic]
-General Imaging [Abdominal, Breast, Musculo-skeletal, Neonatal, Pediatric, Small Organs (Testicles), Thyroid,
Urological ] with invasive access Intraoperative (Abdominal), Laparoscopic,Transrectal.
-Women Health [OB/Fetal, Gynecology with invasive access (Transrectal, Transvaginal)]
The equipment provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in
vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
The ultrasonic medical diagnostic equipment is intended to be connected to mechanical and electronic ultrasound probes
(convex array, linear array and phased array) and Doppler probes.
The Fiber Guidance option assists ultrasound guidance in the phases of insertion and positioning of the introducer needle
and optical fiber and procedure monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212021: 6430 MyLabX75, 6430 MyLab XPro75.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212021
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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