510(k) · Cleared
Recalled · 2007Ssa-770A, Aplio Version 5.5
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 Jun 10, 2004 as substantially equivalent to K032281 (Toshiba America Medical Systems, In.C, 2003) after a 3-day review. Its family tree reaches back 7 generations to 1989. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Jun 10, 2004
- Review
- 3 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 7 generations to K894632 (1989). 38 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 6 generations backK941593 Diagnostic Ultrasonic TransducerToshiba America Medical Systems, In.C · 1996
- 5 generations backK970047 Phased Array Transducer - - PSK-20CTToshiba America Medical Systems, In.C · 1997
- 4 generations backK991858 Ssa-390A/Power Vision 8000Toshiba America Medical Systems, In.C · 1999
- 3 generations backK013633 Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C · 2001
- 2 generations backK022400 Ssa-700A, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2002 · Recalled
- 1 generation backK032281 Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2003
- This deviceK041499 Ssa-770A, Aplio Version 5.5Toshibamedical Systems Corporation · 2004
- Descendant · cites it directly · 0 of its ownK053043 Encompass Software PackageToshiba America Medical Systems, In.C · 2005
- Descendant · cites it directly · 0 of its ownK050380 Xario Diagnostic Ultrasound System, Model Ssa-660AToshiba America Medical Systems, In.C · 2005 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K894632 | Model SSH-140A Ultrasound Imaging System | Toshiba America Medical Systems, In.C | 1989 | — |
| −6 | K941593 | Diagnostic Ultrasonic Transducer | Toshiba America Medical Systems, In.C | 1996 | — |
| −5 | K970047 | Phased Array Transducer - - PSK-20CT | Toshiba America Medical Systems, In.C | 1997 | — |
| −4 | K991858 | Ssa-390A/Power Vision 8000 | Toshiba America Medical Systems, In.C | 1999 | — |
| −3 | K013633 | Ssa-770A, Aplio Ultrasound System | Toshiba America Medical Systems, In.C | 2001 | — |
| −2 | K022400 | Ssa-700A, Aplio Diagnostic Ultrasound System | Toshiba America Medical Systems, In.C | 2002 | 1 |
| −1 | K032281 | Ssa-770A - Version 4, Aplio Diagnostic Ultrasound System | Toshiba America Medical Systems, In.C | 2003 | — |
| 0 (this device) | K041499 | Ssa-770A, Aplio Version 5.5 | Toshibamedical Systems Corporation | 2004 | — |
| +1 | K053043 | Encompass Software Package | Toshiba America Medical Systems, In.C | 2005 | — |
| +1 | K050380 | Xario Diagnostic Ultrasound System, Model Ssa-660A | Toshiba America Medical Systems, In.C | 2005 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 2 | 0 |
| 1997 | 6 | 0 |
| 1998 | 2 | 0 |
| 1999 | 6 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 |
|---|---|---|---|
| * | K032281 | Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemSummary page 1…Medical Systems believes that this device is substantially equivalent to: 1) Toshiba SSA-770A, Aplio Version 4.0 Diagnostic Ultrasound; 510(k) control number k032281 2) Siemens Medical Solutions Sequoia 8.0 Diagnostic Ultrasound System; 510(k) control number k032281 Device Descripti… | 2003 |
What descends from it? (2)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 12, 2007 | Not classified | Z-1171-2010 | Component design/selection | Toshiba America Medical System Inc initiated a field corrective action on Aplio 50; SSA-700A; software version 5.5r002 and later, Aplio 80; SSA-700A; software version 5.5r002 and later, and Xario; SSA-660A; software version 1.0 and later… |
| Nov 12, 2007 | Not classified | Z-1172-2010 | Component design/selection | Toshiba America Medical System Inc initiated a field corrective action on Aplio 50; SSA-700A; software version 5.5r002 and later, Aplio 80; SSA-700A; software version 5.5r002 and later, and Xario; SSA-660A; software version 1.0 and later… |
| Feb 2, 2007 | Not classified | Z-0985-2007 | Other | When using the LV measurement function and making numerous measurements the value displayed on the image screen may on occasion not update correctly. The values that are stored in MDA (measurement display area) are correct and no issue… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 3 of the 38 ancestors have a recall of any class.
- Of its descendants, K053043 (Toshiba America Medical Systems, In.C, 2005) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K032281.
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.
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 APLIO is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular, musculo-skeletal (both conventional and superficial) and laparoscopic.
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/K041499 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041499: Ssa-770A, Aplio Version 5.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041499
Report an extraction error
Are you the manufacturer?
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