510(k) · Cleared
ClearedES1 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
E-Scopics · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jan 11, 2022 as substantially equivalent to K203273 (Echosens, 2021) after a 109-day review. Its family tree reaches back 23 generations to 1995. 3 later devices descend from it.
- Decided
- Jan 11, 2022
- Review
- 109 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 23 generations to K935595 (1995). 162 ancestors in all, the oldest K894632 (1989). 3 later devices descend from it, 1 citing it directly.
- Root · 23 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 19 generations between
- 3 generations backK173034 FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and…Echosens · 2017
- 2 generations backK181547 FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and…Echosens · 2018
- 1 generation backK203273 FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430…Echosens · 2021
- This deviceK213102 ES1 SystemE-Scopics · 2022
- Descendant · cites it directly · 2 of its ownK232336 ES Series V2E-Scopics · 2023
- Descendant · 2 generations on · 0 of its ownK260748 ES-SeriesE-Scopics · 2026
- Descendant · 2 generations on · 0 of its ownK260589 ES-SeriesE-Scopics · 2026
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 backK110870 Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound…Toshiba America Medical Systems, In.C · 2011
- 9 generations backK121422 Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan · 2012
- 8 generations backK123992 Aplio 500/400/300 V3.0Toshibamedical Systems Corporation · 2013
- 7 generations backK133761 Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation · 2014
- 6 generations backK142517 SoftVueDelphinus Medical Technologies, Inc. · 2014
- 5 generations backK150949 FibroScanEchosens · 2015
- 4 generations backK160524 FibroScan 530 CompactEchosens · 2016
- 3 generations backK173034 FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and…Echosens · 2017
- 2 generations backK181547 FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and…Echosens · 2018
- 1 generation backK203273 FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430…Echosens · 2021
- This deviceK213102 ES1 SystemE-Scopics · 2022
Most influential descendants
Showing 3 of 3 · See allView 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 | K110870 | Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio… | Toshiba America Medical Systems, In.C | 2011 | — |
| −9 | K121422 | Aplio 500/400/300 Diagnostic Ultrasound System | Toshiba Medical Systems Coporation, Japan | 2012 | — |
| −8 | K123992 | Aplio 500/400/300 V3.0 | Toshibamedical Systems Corporation | 2013 | — |
| −7 | K133761 | Aplio 500/400/300 Diagnostic Ultrasound System V4.0 | Toshibamedical Systems Corporation | 2014 | — |
| −6 | K142517 | SoftVue | Delphinus Medical Technologies, Inc. | 2014 | — |
| −5 | K150949 | FibroScan | Echosens | 2015 | — |
| −4 | K160524 | FibroScan 530 Compact | Echosens | 2016 | — |
| −3 | K173034 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) | Echosens | 2017 | — |
| −2 | K181547 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) | Echosens | 2018 | — |
| −1 | K203273 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and… | Echosens | 2021 | — |
| 0 (this device) | K213102 | ES1 System | E-Scopics | 2022 | — |
| +1 | K232336 | ES Series V2 | E-Scopics | 2023 | — |
| +2 | K260748 | ES-Series | E-Scopics | 2026 | — |
| +2 | K260589 | ES-Series | E-Scopics | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 8 | 0 |
| 1996 | 3 | 0 |
| 1997 | 9 | 0 |
| 1998 | 4 | 0 |
| 1999 | 11 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 11 | 0 |
| 2003 | 13 | 0 |
| 2004 | 14 | 0 |
| 2005 | 10 | 0 |
| 2006 | 9 | 0 |
| 2007 | 3 | 0 |
| 2008 | 8 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2026 | 2 | 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.
Planning a device in IYN? 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 |
|---|---|---|---|
| * | K203273 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Summary page 5…and information supplied in this submission demonstrates substantial equivalence to their respective predicate devices : Predicate Device: FibroScan® Family of Products (K203273), cleared on 03/25/2021. Reference Devices: AIXPLORER® MACH 20 & 30 Ultrasound Diagnostic Systems (K191007), cleared on 10/25/201… | 2021 |
| † | K191007 | Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems | 2019 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232336 | ES Series V2 | 2023 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 11 companies; a new generation was cleared every 10 months on median.
- 33 of the 162 ancestors have a recall of any class.
- Of its descendants, K232336 (E-Scopics, 2023) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K203273.
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. 2022, 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 ES1 Ultrasound Diagnostic System is intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging of the human body and provides measurements of shear wave speed and tissue stiffness, ultrasound beam attenuation and estimates of speed of sound, in internal structures of the body. This device is intended to be used by trained healthcare professionals, in a healthcare environment. The ES1 Ultrasound Diagnostic System is…
Read the full statement (199 words)
The ES1 Ultrasound Diagnostic System is intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging of the human body and provides measurements of shear wave speed and tissue stiffness, ultrasound beam attenuation and estimates of speed of sound, in internal structures of the body. This device is intended to be used by trained healthcare professionals, in a healthcare environment.
The ES1 Ultrasound Diagnostic System is indicated for imaging of anatomical structures in the abdomen and measurements of physical properties in the liver and the spleen.
In particular, the ES1 ultrasound diagnostic system is intended to provide:
- Linear distance measurements of anatomical structures,
- Measurement of shear wave speed at selected shear wave frequencies, and estimates of tissue stiffness in the liver and the spleen,
- Estimates of ultrasound attenuation coefficient in the liver at 3.5 MHz,
- Measurement of brightness ratio between structures and in particular between the liver and the kidney,
- Estimates of speed of sound in the liver.
The shear wave speed measurements, ultrasound beam attenuation, elastic properties estimates, brightness ratio may be used as an aid to the diagnosis, monitoring and clinical management of adult and pediatric patients with liver disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213102 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213102: ES1 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213102
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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