510(k) · Cleared
Cleared6200 Ultrasound System and 6250 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 May 4, 2016 as substantially equivalent to K133905 (Esaote, S.p.A., 2014) and 4 other predicates after a 174-day review. Its family tree reaches back 17 generations to 1995. 1 of the 231 devices in its family, counting itself, has a Class I recall. 12 later devices descend from it.
- Decided
- May 4, 2016
- Review
- 174 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 17 generations to K935595 (1995). 218 ancestors in all, the oldest K863700 (1987). 12 later devices descend from it, 2 citing it directly. 1 of the 231 devices in this family, counting this one, has a Class I recall.
- Root · 17 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 13 generations between
- 3 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 2 generations backK123564 Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2012 · Recalled
- 1 generation backK133905 6200 / 6250 Ultrasound SystemEsaote, S.p.A. · 2014
- This deviceK153277 6200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2016
- Descendant · cites it directly · 9 of its ownK163082 6200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2017 · Recalled
- Descendant · 2 generations on · 8 of its ownK173291 6440 Ultrasound SystemEsaote, S.p.A. · 2018
- Descendant · 3 generations on · 4 of its ownK230179 6440 MyLabX90Esaote, S.p.A. · 2023 · Recalled
- Descendant · 3 generations on · 4 of its ownK192157 6450 Ultrasound systemEsaote, S.p.A. · 2019
- Descendant · 4 generations on · 2 of its ownK243253 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A. · 2025
Show all 17 generations
- Root · 17 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 16 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 15 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 14 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 13 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 12 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 11 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 10 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 9 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 8 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 7 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 6 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 5 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 4 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 3 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 2 generations backK123564 Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2012 · Recalled
- 1 generation backK133905 6200 / 6250 Ultrasound SystemEsaote, S.p.A. · 2014
- This deviceK153277 6200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2016
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K070106 VV Fluoro 3D3 generations back · 2007
Most influential descendants
Showing 5 of 12 · See all- K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2017 · cites it directly9descendants
- K1732916440 Ultrasound SystemEsaote, S.p.A. · 2018 · 2 generations on8descendants
- K2301796440 MyLabX90Esaote, S.p.A. · 2023 · 3 generations on4descendants
- K1921576450 Ultrasound systemEsaote, S.p.A. · 2019 · 3 generations on4descendants
- K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A. · 2025 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −16 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −15 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −14 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −13 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −12 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −11 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −10 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −9 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −8 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −7 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −6 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −5 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −4 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −3 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −2 | K123564 | Logiq E9 Diagnostic Ultrasound System | GE Healthcare | 2012 | 1 |
| −1 | K133905 | 6200 / 6250 Ultrasound System | Esaote, S.p.A. | 2014 | — |
| 0 (this device) | K153277 | 6200 Ultrasound System and 6250 Ultrasound System | Esaote, S.p.A. | 2016 | — |
| +1 | K163082 | 6200 Ultrasound System and 6250 Ultrasound System | Esaote, S.p.A. | 2017 | 2 |
| +2 | K173291 | 6440 Ultrasound System | Esaote, S.p.A. | 2018 | — |
| +3 | K230179 | 6440 MyLabX90 | Esaote, S.p.A. | 2023 | 1 |
| +3 | K192157 | 6450 Ultrasound system | Esaote, S.p.A. | 2019 | — |
| +4 | K243253 | 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) | Esaote, S.p.A. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 7 | 0 |
| 1996 | 2 | 0 |
| 1997 | 8 | 0 |
| 1998 | 8 | 0 |
| 1999 | 14 | 0 |
| 2000 | 14 | 0 |
| 2001 | 15 | 0 |
| 2002 | 15 | 0 |
| 2003 | 20 | 0 |
| 2004 | 20 | 0 |
| 2005 | 19 | 0 |
| 2006 | 14 | 0 |
| 2007 | 5 | 1 |
| 2008 | 7 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2011 | 8 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 3 | 0 |
| 2018 | 2 | 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.
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? (5)
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 |
|---|---|---|---|
| * | K133905 | 6200 / 6250 Ultrasound SystemSummary page 5…Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border Previously cleared via k100931, k133905 3UHVFULSWLRQ8VH2QO\3HU&)53DUW'&RQFXUUHQFHRI… | 2014 |
| * | K142008 | Mylabseven, MylabalphaSummary page 9…hy [9] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border Previously cleared via k142008 3UHVFULSWLRQ8VH2QO\3HU&)53DUW'&RQFXUUHQFHRI… | 2014 |
| * | K061961 | Art Lab SoftwareSummary page 47…aote K142008 Reference Arietta 70 Hitachi Aloka K134016 Reference ART.LAB Esaote Europe K061961 Reference Preirus Hitachi Aloka K093466 K153277 Esaote Response to FDA Deficiencies… | 2006 |
| * | K093466 | HI Vision Preirus Doagnostic Ultrasound Scanner Model HI Vision PreirusSummary page 47…tachi Aloka K134016 Reference ART.LAB Esaote Europe K061961 Reference Preirus Hitachi Aloka K093466 K153277 Esaote Response to FDA Deficiencies Page 33 of 74 510(k… | 2010 |
| * | K134016 | Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerSummary page 47…aote K133905 Reference 6400 Esaote K142008 Reference Arietta 70 Hitachi Aloka K134016 Reference ART.LAB Esaote Europe K061961 Reference Preirus… | 2014 |
What descends from it? (12)
See all 122 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 · 3 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 12 months on median.
- 54 of the 218 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K163082 (Esaote, S.p.A., 2017) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K133905.
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. 2016, 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 Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Intraoperative (Neurological), Laparoscopic and Other: Urologic. The 6200 system provides imaging for…
Read the full statement (307 words)
Esaote’s Model 6200 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including
Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs,
Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative
(Abdominal), Intraoperative (Neurological), Laparoscopic and Other: Urologic. The 6200 system provides imaging for
guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as
peripheral nerve blocks in Musculoskeletal applications.
Esaote’s Model 6250 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including
Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs,
Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative
(Abdominal), Intraoperative (Neurological), Laparoscopic and Other: Urologic. The 6250 system provides imaging for
guidance of biopsy and 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 software option for Esaote models 6200 and 6250 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 ultrasound image.
Virtual Navigator can be used in the following application: Abdominal, Gynecological, Musculo-skeletal, Obstetrics, Pediatric, Urologic, Small Organs, 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 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 as stated in the FDA summary.
https://510kreport.com/device/K153277 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153277: 6200 Ultrasound System and 6250 Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153277
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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