510(k) · Cleared
ClearedFibroScan
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 Jun 3, 2015 as substantially equivalent to K123806 (Echosens, 2013) and 1 other predicate after a 56-day review. Its family tree reaches back 18 generations to 1995. 42 later devices descend from it.
- Decided
- Jun 3, 2015
- Review
- 56 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 18 generations to K935595 (1995). 154 ancestors in all, the oldest K894632 (1989). 42 later devices descend from it, 1 citing it directly.
- Root · 18 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 14 generations between
- 3 generations backK123992 Aplio 500/400/300 V3.0Toshibamedical Systems Corporation · 2013
- 2 generations backK133761 Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation · 2014
- 1 generation backK142517 SoftVueDelphinus Medical Technologies, Inc. · 2014
- This deviceK150949 FibroScanEchosens · 2015
- Descendant · cites it directly · 41 of its ownK160524 FibroScan 530 CompactEchosens · 2016
- Descendant · 2 generations on · 19 of its ownK170445 Logiq S8GE Healthcare · 2017 · Recalled
- Descendant · 2 generations on · 18 of its ownK173021 Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine · 2018
- Descendant · 2 generations on · 16 of its ownK180572 AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30…Supersonic Imagine · 2018
- Descendant · 2 generations on · 15 of its ownK173034 FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and…Echosens · 2017
Show all 18 generations
- Root · 18 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 17 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 16 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 15 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 14 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 13 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 12 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 11 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 10 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 9 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 8 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 7 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 6 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 5 generations backK110870 Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound…Toshiba America Medical Systems, In.C · 2011
- 4 generations backK121422 Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan · 2012
- 3 generations backK123992 Aplio 500/400/300 V3.0Toshibamedical Systems Corporation · 2013
- 2 generations backK133761 Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation · 2014
- 1 generation backK142517 SoftVueDelphinus Medical Technologies, Inc. · 2014
- This deviceK150949 FibroScanEchosens · 2015
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K160524FibroScan 530 CompactEchosens · 2016 · cites it directly41descendants
- K170445Logiq S8GE Healthcare · 2017 · 2 generations on19descendants
- K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine · 2018 · 2 generations on18descendants
- K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine · 2018 · 2 generations on16descendants
- K173034FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens · 2017 · 2 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −17 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −16 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −15 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −14 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −13 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −12 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −11 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −10 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −9 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −8 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −7 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −6 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −5 | K110870 | Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio… | Toshiba America Medical Systems, In.C | 2011 | — |
| −4 | K121422 | Aplio 500/400/300 Diagnostic Ultrasound System | Toshiba Medical Systems Coporation, Japan | 2012 | — |
| −3 | K123992 | Aplio 500/400/300 V3.0 | Toshibamedical Systems Corporation | 2013 | — |
| −2 | K133761 | Aplio 500/400/300 Diagnostic Ultrasound System V4.0 | Toshibamedical Systems Corporation | 2014 | — |
| −1 | K142517 | SoftVue | Delphinus Medical Technologies, Inc. | 2014 | — |
| 0 (this device) | K150949 | FibroScan | Echosens | 2015 | — |
| +1 | K160524 | FibroScan 530 Compact | Echosens | 2016 | — |
| +2 | K170445 | Logiq S8 | GE Healthcare | 2017 | 1 |
| +2 | K173021 | Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems | Supersonic Imagine | 2018 | — |
| +2 | K180572 | AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach… | Supersonic Imagine | 2018 | — |
| +2 | K173034 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) | Echosens | 2017 | — |
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 | 1 | 0 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 6 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 6 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K123806 | FibroscanSummary page 8…3010258456 Predicate Device This submission claims substantial equivalence to a combination of three cleared devices: Primary Predicate: FibroScan® (#K123806) manufactured by the sponsor and cleared on April 5, 2013; and… | 2013 |
| * | K142517 | SoftVueSummary page 9…Page 1 of 4 Secondary Predicate: SoftVue® (#K142517) manufactured by Dephinus Medical Technologies, Inc. and cleared on October 31, 2014 Device Description FibroScan®… | 2014 |
What descends from it? (42)
See all 421 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160524 | FibroScan 530 Compact | 2016 | 41 |
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 20 years and passes through 10 companies; a new generation was cleared every 11 months on median.
- 33 of the 154 ancestors have a recall of any class.
- Of its descendants, K160524 (Echosens, 2016) has gone furthest, with 41 descendants of its own.
- 2 other devices also cite its predicate K123806.
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. 2015, 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® system is intended to provide 50Hz 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® 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…
Read the full statement (111 words)
The FibroScan® system is intended to provide 50Hz 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® 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 clinical management of adult patients with liver disease.
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/K150949 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150949: FibroScan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150949
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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