510(k) · Cleared
ClearedAplio 500/400/300 Diagnostic Ultrasound System V4.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshibamedical Systems Corporation · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Apr 22, 2014 as substantially equivalent to K123992 (Toshibamedical Systems Corporation, 2013) after a 132-day review. Its family tree reaches back 16 generations to 1995. 72 later devices descend from it.
- Decided
- Apr 22, 2014
- Review
- 132 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K935595 (1995). 132 ancestors in all, the oldest K894632 (1989). 72 later devices descend from it, 3 citing it directly.
- Root · 16 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 12 generations between
- 3 generations backK110870 Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound…Toshiba America Medical Systems, In.C · 2011
- 2 generations backK121422 Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan · 2012
- 1 generation backK123992 Aplio 500/400/300 V3.0Toshibamedical Systems Corporation · 2013
- This deviceK133761 Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation · 2014
- Descendant · cites it directly · 49 of its ownK142517 SoftVueDelphinus Medical Technologies, Inc. · 2014
- Descendant · 2 generations on · 42 of its ownK150949 FibroScanEchosens · 2015
- Descendant · 3 generations on · 41 of its ownK160524 FibroScan 530 CompactEchosens · 2016
- Descendant · cites it directly · 39 of its ownK141459 Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation · 2014
- Descendant · 2 generations on · 34 of its ownK151451 Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation · 2015 · Recalled
Show all 16 generations
- Root · 16 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 15 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 14 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 13 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 12 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 11 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 10 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 9 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 8 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 7 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 6 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 5 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 4 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 3 generations backK110870 Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound…Toshiba America Medical Systems, In.C · 2011
- 2 generations backK121422 Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan · 2012
- 1 generation backK123992 Aplio 500/400/300 V3.0Toshibamedical Systems Corporation · 2013
- This deviceK133761 Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation · 2014
Showing 5 of 72 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 72 · See all- K142517SoftVueDelphinus Medical Technologies, Inc. · 2014 · cites it directly49descendants
- K150949FibroScanEchosens · 2015 · 2 generations on42descendants
- K160524FibroScan 530 CompactEchosens · 2016 · 3 generations on41descendants
- K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation · 2014 · cites it directly39descendants
- K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation · 2015 · 2 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −15 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −14 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −13 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −12 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −11 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −10 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −9 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −8 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −7 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −6 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −5 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −4 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −3 | K110870 | Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio… | Toshiba America Medical Systems, In.C | 2011 | — |
| −2 | K121422 | Aplio 500/400/300 Diagnostic Ultrasound System | Toshiba Medical Systems Coporation, Japan | 2012 | — |
| −1 | K123992 | Aplio 500/400/300 V3.0 | Toshibamedical Systems Corporation | 2013 | — |
| 0 (this device) | K133761 | Aplio 500/400/300 Diagnostic Ultrasound System V4.0 | Toshibamedical Systems Corporation | 2014 | — |
| +1 | K142517 | SoftVue | Delphinus Medical Technologies, Inc. | 2014 | — |
| +2 | K150949 | FibroScan | Echosens | 2015 | — |
| +3 | K160524 | FibroScan 530 Compact | Echosens | 2016 | — |
| +1 | K141459 | Aplio 500/400/300 Diagnostic Ultrasound System, V5.0 | Toshibamedical Systems Corporation | 2014 | — |
| +2 | K151451 | Aplio 500/400/300 Diagnostic Ultrasound System V6.0 | Toshibamedical Systems Corporation | 2015 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 8 | 0 |
| 1996 | 3 | 0 |
| 1997 | 9 | 0 |
| 1998 | 4 | 0 |
| 1999 | 10 | 0 |
| 2000 | 6 | 0 |
| 2001 | 7 | 0 |
| 2002 | 7 | 0 |
| 2003 | 10 | 0 |
| 2004 | 12 | 0 |
| 2005 | 9 | 0 |
| 2006 | 9 | 0 |
| 2007 | 3 | 0 |
| 2008 | 7 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 7 | 0 |
| 2018 | 10 | 0 |
| 2019 | 5 | 0 |
| 2020 | 7 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 6 | 0 |
| 2024 | 6 | 0 |
| 2025 | 8 | 0 |
| 2026 | 7 | 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 |
|---|---|---|---|
| * | K123992 | Aplio 500/400/300 V3.0Summary page 1…Product Marketed by 510(k) Number Clearance Date Aplio 500/400/300 Diagnostic Toshiba America K123992 February 6,2013 Ultrasound System Medical Systems… | 2013 |
What descends from it? (72)
See all 723 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 19 years and passes through 8 companies; a new generation was cleared every 11 months on median.
- 30 of the 132 ancestors have a recall of any class.
- Of its descendants, K142517 (Delphinus Medical Technologies, Inc., 2014) has gone furthest, with 49 descendants of its own.
- 1 other device also cites its predicate K123992.
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. 2014, 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 Diagnostic Ultrasound System Aplio 500 Model TUS-A500, Aplio 400 Model TUS-A400 and Aplio 300 Model TUS-A300 is indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, and musculo-skeletal (both conventional and superficial).
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/K133761 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133761: Aplio 500/400/300 Diagnostic Ultrasound System V4.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133761
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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