510(k) · Cleared
Cleared7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)
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 Nov 25, 2025 as substantially equivalent to K243253 (Esaote, S.p.A., 2025) and 1 other predicate after a 57-day review. Its family tree reaches back 23 generations to 1995. 7 of the 340 devices in its family, counting itself, have a Class I recall.
- Decided
- Nov 25, 2025
- Review
- 57 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 23 generations to K935595 (1995). 339 ancestors in all, the oldest K844472 (1985). No later device cites it as a predicate yet. 7 of the 340 devices in this family, counting this one, have a Class I recall.
- Root · 23 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 19 generations between
- 3 generations backK173291 6440 Ultrasound SystemEsaote, S.p.A. · 2018
- 2 generations backK192157 6450 Ultrasound systemEsaote, S.p.A. · 2019
- 1 generation backK241671 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A. · 2025
- This deviceK253310 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A. · 2025
Show all 23 generations
- Root · 23 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 22 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 21 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 20 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 19 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 18 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 17 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 16 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 15 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 14 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 13 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 12 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 11 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 10 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 9 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 8 generations backK120741 Voluson S6, Voluson S8GE Healthcare · 2012
- 7 generations backK122387 Voluson P6, Voluson P8GE Healthcare · 2012
- 6 generations backK131937 Voluson I/EGE Healthcare · 2013
- 5 generations backK151451 Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation · 2015 · Recalled
- 4 generations backK163082 6200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2017 · Recalled
- 3 generations backK173291 6440 Ultrasound SystemEsaote, S.p.A. · 2018
- 2 generations backK192157 6450 Ultrasound systemEsaote, S.p.A. · 2019
- 1 generation backK241671 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A. · 2025
- This deviceK253310 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A. · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −22 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −21 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −20 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −19 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −18 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −17 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −16 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −15 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −14 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −13 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −12 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −11 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −10 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −9 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −8 | K120741 | Voluson S6, Voluson S8 | GE Healthcare | 2012 | — |
| −7 | K122387 | Voluson P6, Voluson P8 | GE Healthcare | 2012 | — |
| −6 | K131937 | Voluson I/E | GE Healthcare | 2013 | — |
| −5 | K151451 | Aplio 500/400/300 Diagnostic Ultrasound System V6.0 | Toshibamedical Systems Corporation | 2015 | 2 |
| −4 | K163082 | 6200 Ultrasound System and 6250 Ultrasound System | Esaote, S.p.A. | 2017 | 2 |
| −3 | K173291 | 6440 Ultrasound System | Esaote, S.p.A. | 2018 | — |
| −2 | K192157 | 6450 Ultrasound system | Esaote, S.p.A. | 2019 | — |
| −1 | K241671 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | Esaote, S.p.A. | 2025 | — |
| 0 (this device) | 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 |
| 2025 | 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 |
|---|---|---|---|
| * | K243253 | 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Summary page 5…only in the licenses configuration. 7600 Ultrasound System, defined herein, is a new portabi e version of the cart-based 6600 Ultrasound System previously cleared under K243253. 1 ne proposea 1ouu uItrasouna :,ystem mcIuaes a new sonware versIon u1at comomes reatures i-uA-cIearea ana aIrea… | 2025 |
| * | K241671 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Summary page 6…roposea 1ouu uItrasouna :,ystem mcIuaes a new sonware versIon u1at comomes reatures i-uA-cIearea ana aIreaay ava11aoie in me predicate and reference devices (K243253 and K241671 ). No new functionalities have been introduced in the current software release compared to the version previously cleared. 7600 U… | 2025 |
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 · 8 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 · 8 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 9 generations back · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 9 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 9 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 9 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 9 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 11 months on median.
- 87 of the 339 ancestors have a recall of any class; 7 have a Class I recall.
- 1 other device also cites its predicate K243253.
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 applications - Cardiac Districts: Cardiac Adult, Cardiac Pediatric (including newborns) Invasive access: Transesophageal - Vascular Districts: Neonatal, Adult Cephalic, Vascular Invasive access: Not applicable - General Imaging Districts: Abdominal, Musculo-skeletal…
Read the full statement (130 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 applications
- Cardiac
Districts: Cardiac Adult, Cardiac Pediatric (including newborns)
Invasive access: Transesophageal
- Vascular
Districts: Neonatal, Adult Cephalic, Vascular
Invasive access: Not applicable
- General Imaging
Districts: Abdominal, Musculo-skeletal, Neonatal, Pediatric, Small Organ (Testicles, Breast, Thyroid),
Urologic
Invasive access: Intraoperative (Abdominal), Laparoscopic, Transrectal
- Women Health
Districts: OB/Fetal, Gynecology
Invasive access: Transrectal, Transvaginal
The primary modes of operation are: B-Mode, M-Mode, Tissue Enhancement Imaging (TEl), Multi View
(MView), Doppler (both PW and CW), Color Flow Mapping (CFM), Power Doppler, Tissue Velocity Mapping
(TVM), Combined modes, Elastosonography, 3D/4D and CnTI.
The ultrasound scanner is suitable for use in health institutions and is designed for ultrasound practitioners.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253310 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253310: 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253310
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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