510(k) · Cleared
ClearedFibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Echosens · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Jul 9, 2018 as substantially equivalent to K173034 (Echosens, 2017) and 1 other predicate after a 27-day review. Its family tree reaches back 21 generations to 1995. 14 later devices descend from it.
- Decided
- Jul 9, 2018
- Review
- 27 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 21 generations to K935595 (1995). 160 ancestors in all, the oldest K894632 (1989). 14 later devices descend from it, 3 citing it directly.
- Root · 21 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 17 generations between
- 3 generations backK150949 FibroScanEchosens · 2015
- 2 generations backK160524 FibroScan 530 CompactEchosens · 2016
- 1 generation backK173034 FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and…Echosens · 2017
- This deviceK181547 FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and…Echosens · 2018
- Descendant · cites it directly · 9 of its ownK203273 FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430…Echosens · 2021
- Descendant · 2 generations on · 5 of its ownK212035 FibroScan 230Echosens · 2021
- Descendant · 2 generations on · 3 of its ownK213102 ES1 SystemE-Scopics · 2022
- Descendant · 3 generations on · 2 of its ownK233401 Portable Liver Elastography Ultrasound Diagnostic System (Liverscan…Eieling Technology Limited · 2024
- Descendant · 3 generations on · 2 of its ownK232336 ES Series V2E-Scopics · 2023
Show all 21 generations
- Root · 21 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 20 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 19 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 18 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 17 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 16 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 15 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 14 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 13 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 12 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 11 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 10 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 9 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 8 generations backK110870 Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound…Toshiba America Medical Systems, In.C · 2011
- 7 generations backK121422 Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan · 2012
- 6 generations backK123992 Aplio 500/400/300 V3.0Toshibamedical Systems Corporation · 2013
- 5 generations backK133761 Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation · 2014
- 4 generations backK142517 SoftVueDelphinus Medical Technologies, Inc. · 2014
- 3 generations backK150949 FibroScanEchosens · 2015
- 2 generations backK160524 FibroScan 530 CompactEchosens · 2016
- 1 generation backK173034 FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and…Echosens · 2017
- This deviceK181547 FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and…Echosens · 2018
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens · 2021 · cites it directly9descendants
- K212035FibroScan 230Echosens · 2021 · 2 generations on5descendants
- K213102ES1 SystemE-Scopics · 2022 · 2 generations on3descendants
- K233401Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)Eieling Technology Limited · 2024 · 3 generations on2descendants
- K232336ES Series V2E-Scopics · 2023 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −20 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −19 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −18 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −17 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −16 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −15 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −14 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −13 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −12 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −11 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −10 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −9 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −8 | K110870 | Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio… | Toshiba America Medical Systems, In.C | 2011 | — |
| −7 | K121422 | Aplio 500/400/300 Diagnostic Ultrasound System | Toshiba Medical Systems Coporation, Japan | 2012 | — |
| −6 | K123992 | Aplio 500/400/300 V3.0 | Toshibamedical Systems Corporation | 2013 | — |
| −5 | K133761 | Aplio 500/400/300 Diagnostic Ultrasound System V4.0 | Toshibamedical Systems Corporation | 2014 | — |
| −4 | K142517 | SoftVue | Delphinus Medical Technologies, Inc. | 2014 | — |
| −3 | K150949 | FibroScan | Echosens | 2015 | — |
| −2 | K160524 | FibroScan 530 Compact | Echosens | 2016 | — |
| −1 | K173034 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) | Echosens | 2017 | — |
| 0 (this device) | 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 | — |
| +2 | K212035 | FibroScan 230 | Echosens | 2021 | — |
| +2 | K213102 | ES1 System | E-Scopics | 2022 | — |
| +3 | K233401 | Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) | Eieling Technology Limited | 2024 | — |
| +3 | K232336 | ES Series V2 | E-Scopics | 2023 | — |
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 |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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 IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 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 |
|---|---|---|---|
| * | K173034 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Summary page 10…=== Predicate Device This submission claims substantial equivalence to a combination of two previously cleared devices: 1. Echosens’s FibroScan® Family of Products (#K173034) cleared on November 14, 2017; and 2. Echosens’s FibroScan® System (#K150239) cleared on September 1, 2015. Device De… | 2017 |
| * | K150239 | FibroScanSummary page 10…f two previously cleared devices: 1. Echosens’s FibroScan® Family of Products (#K173034) cleared on November 14, 2017; and 2. Echosens’s FibroScan® System (#K150239) cleared on September 1, 2015. Device Description FibroScan® system consists of a system unit and a hand-held probe. It is base… | 2015 |
What descends from it? (14)
See all 143 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 10 companies; a new generation was cleared every 10 months on median.
- 33 of the 160 ancestors have a recall of any class.
- Of its descendants, K203273 (Echosens, 2021) has gone furthest, with 9 descendants of its own.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
The FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) is intended to provide 5S0Hz shear wave speed measurements and estimates of tissue stiffness as well as 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter) in internal structures of the body. FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) is indicated for noninvasive measurement in the liver of 50 Hz shear…
Read the full statement (142 words)
The FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) is intended to provide 5S0Hz shear wave speed measurements and estimates of tissue stiffness as well as 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter) in internal structures of the body.
FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) is indicated for noninvasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as 3.5 MHz ultrasound coefficient
of attenuation (CAP: Controlled Attenuation Parameter).
The shear wave speed and stiffness, and CAP may be used as an aid to diagnosis and monitoring of adult patients with liver disease, as part of an overall assessment of the liver.
Shear wave speed and stiffness may be used as an aid to clinical management of pediatric patients with liver disease.
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/K181547 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181547: FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181547
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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