510(k) · Cleared
Cleared6440 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 Jan 12, 2018 as substantially equivalent to K163082 (Esaote, S.p.A., 2017) after an 88-day review. Its family tree reaches back 20 generations to 1995. 7 of the 343 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it.
- Decided
- Jan 12, 2018
- Review
- 88 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 20 generations to K935595 (1995). 334 ancestors in all, the oldest K844472 (1985). 8 later devices descend from it, 3 citing it directly. 7 of the 343 devices in this family, counting this one, have a Class I recall.
- Root · 20 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 16 generations between
- 3 generations backK131937 Voluson I/EGE Healthcare · 2013
- 2 generations backK151451 Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation · 2015 · Recalled
- 1 generation backK163082 6200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2017 · Recalled
- This deviceK173291 6440 Ultrasound SystemEsaote, S.p.A. · 2018
- Descendant · cites it directly · 4 of its ownK230179 6440 MyLabX90Esaote, S.p.A. · 2023 · Recalled
- Descendant · cites it directly · 4 of its ownK192157 6450 Ultrasound systemEsaote, S.p.A. · 2019
- Descendant · 2 generations on · 2 of its ownK243253 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A. · 2025
- Descendant · 2 generations on · 2 of its ownK241671 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A. · 2025
- Descendant · 3 generations on · 0 of its ownK253288 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A. · 2026
Show all 20 generations
- Root · 20 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 19 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 18 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 17 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 16 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 15 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 14 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 13 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 12 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 11 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 10 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 9 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 8 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 7 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 6 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 5 generations backK120741 Voluson S6, Voluson S8GE Healthcare · 2012
- 4 generations backK122387 Voluson P6, Voluson P8GE Healthcare · 2012
- 3 generations backK131937 Voluson I/EGE Healthcare · 2013
- 2 generations backK151451 Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation · 2015 · Recalled
- 1 generation backK163082 6200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2017 · Recalled
- This deviceK173291 6440 Ultrasound SystemEsaote, S.p.A. · 2018
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 8 · See all- K2301796440 MyLabX90Esaote, S.p.A. · 2023 · cites it directly4descendants
- K1921576450 Ultrasound systemEsaote, S.p.A. · 2019 · cites it directly4descendants
- K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A. · 2025 · 2 generations on2descendants
- K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A. · 2025 · 2 generations on2descendants
- K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −19 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −18 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −17 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −16 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −15 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −14 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −13 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −12 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −11 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −10 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −9 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −8 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −7 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −6 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −5 | K120741 | Voluson S6, Voluson S8 | GE Healthcare | 2012 | — |
| −4 | K122387 | Voluson P6, Voluson P8 | GE Healthcare | 2012 | — |
| −3 | K131937 | Voluson I/E | GE Healthcare | 2013 | — |
| −2 | K151451 | Aplio 500/400/300 Diagnostic Ultrasound System V6.0 | Toshibamedical Systems Corporation | 2015 | 2 |
| −1 | K163082 | 6200 Ultrasound System and 6250 Ultrasound System | Esaote, S.p.A. | 2017 | 2 |
| 0 (this device) | K173291 | 6440 Ultrasound System | Esaote, S.p.A. | 2018 | — |
| +1 | K230179 | 6440 MyLabX90 | Esaote, S.p.A. | 2023 | 1 |
| +1 | K192157 | 6450 Ultrasound system | Esaote, S.p.A. | 2019 | — |
| +2 | K243253 | 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) | Esaote, S.p.A. | 2025 | — |
| +2 | K241671 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | Esaote, S.p.A. | 2025 | — |
| +3 | K253288 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | Esaote, S.p.A. | 2026 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 3 | 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? (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 |
|---|---|---|---|
| * | K163082 | 6200 Ultrasound System and 6250 Ultrasound SystemSummary page 5…al border [10] Includes contrast (CnTI) in characterization of liver lesions [11] Virtual Navigator [12] Quantitative Elastosonography (QElaXto) Previously cleared via K163082 Prescription Use Only Per 21 CFR 801 Part D Concurrence of… | 2017 |
| † | K161359 | 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System | 2016 |
| † | K150122 | Tomtec-Arena TTA2 | 2015 |
| † | K163077 | LOGIQ E9, LOGIQ E9 XDClear 2.0 | 2016 |
What descends from it? (8)
3 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 · 5 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 · 5 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 6 generations back · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 6 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 6 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 6 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 6 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 23 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 86 of the 334 ancestors have a recall of any class; 7 have a Class I recall.
- Of its descendants, K230179 (Esaote, S.p.A., 2023) has gone furthest, with 4 descendants of its own.
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. 2018, 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 6440 is intended to perform diagnostic general ultrasound studies including: Fetal, Abdominal, Intraoperative (Abdominal), Pediatric, Small organs, Neonatal, Neonatal Cephalic, Adult Cephalic, Transrectal, Transvaginal, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Urological, Cardiovascular Adult, Cardiovascular Pediatric, Transoesophageal (cardiac), Peripheral Vessel. The 6440 system provides imaging for guidance of…
Read the full statement (233 words)
Esaote's Model 6440 is intended to perform diagnostic general ultrasound studies
including: Fetal, Abdominal, Intraoperative (Abdominal), Pediatric, Small organs, Neonatal, Neonatal Cephalic, Adult Cephalic, Transrectal, Transvaginal, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Urological, Cardiovascular Adult, Cardiovascular Pediatric, Transoesophageal (cardiac), Peripheral Vessel.
The 6440 system 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 Virtual Navigator software option for Esaote model 6440 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 real time ultrasound image. Virtual Navigator can be used in the following applications: Abdominal, Gynecological, Musculoskeletal, Obstetrics, Pediatric, Urologic, Small Organs, Intraoperative (Abdominal), Intraoperative (Neurological), 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 be seen as an additional source of information.
The Virtual Navigator tracking system is contraindicated for patients, operators, personnel and other people who use an electronic life support device (such as a cardiac pacemaker or defibrillator).
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/K173291 · printed Nov 3, 2026
Cite this page
510(k) Report. “K173291: 6440 Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K173291
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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