510(k) · Cleared
ClearedSsa-390A/Power Vision 8000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshiba America Medical Systems, In.C · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jun 16, 1999 as substantially equivalent to K933743 (Toshiba America Medical Systems, In.C, 1994) and 4 other predicates after a 15-day review. Its family tree reaches back 3 generations to 1989. 212 later devices descend from it.
- Decided
- Jun 16, 1999
- Review
- 15 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 3 generations to K894632 (1989). 13 ancestors in all. 212 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 2 generations backK941593 Diagnostic Ultrasonic TransducerToshiba America Medical Systems, In.C · 1996
- 1 generation backK970047 Phased Array Transducer - - PSK-20CTToshiba America Medical Systems, In.C · 1997
- This deviceK991858 Ssa-390A/Power Vision 8000Toshiba America Medical Systems, In.C · 1999
- Descendant · cites it directly · 211 of its ownK013633 Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C · 2001
- Descendant · 2 generations on · 210 of its ownK022400 Ssa-700A, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2002 · Recalled
- Descendant · 2 generations on · 209 of its ownK032281 Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2003
- Descendant · 3 generations on · 205 of its ownK063130 Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0Toshibamedical Systems Corporation · 2006 · Recalled
- Descendant · 4 generations on · 203 of its ownK072000 Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0Toshiba America Medical Systems, In.C · 2007
Showing 5 of 212 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 212 · See all- K013633Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C · 2001 · cites it directly211descendants
- K022400Ssa-700A, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2002 · 2 generations on210descendants
- K032281Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2003 · 2 generations on209descendants
- K063130Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0Toshibamedical Systems Corporation · 2006 · 3 generations on205descendants
- K072000Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0Toshiba America Medical Systems, In.C · 2007 · 4 generations on203descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K894632 | Model SSH-140A Ultrasound Imaging System | Toshiba America Medical Systems, In.C | 1989 | — |
| −2 | K941593 | Diagnostic Ultrasonic Transducer | Toshiba America Medical Systems, In.C | 1996 | — |
| −1 | K970047 | Phased Array Transducer - - PSK-20CT | Toshiba America Medical Systems, In.C | 1997 | — |
| 0 (this device) | K991858 | Ssa-390A/Power Vision 8000 | Toshiba America Medical Systems, In.C | 1999 | — |
| +1 | 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 |
| +2 | K032281 | Ssa-770A - Version 4, Aplio Diagnostic Ultrasound System | Toshiba America Medical Systems, In.C | 2003 | — |
| +3 | K063130 | Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0 | Toshibamedical Systems Corporation | 2006 | 1 |
| +4 | K072000 | Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0 | Toshiba America Medical Systems, In.C | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 8 | 0 |
| 2013 | 4 | 0 |
| 2014 | 10 | 0 |
| 2015 | 5 | 0 |
| 2016 | 7 | 0 |
| 2017 | 12 | 0 |
| 2018 | 18 | 0 |
| 2019 | 8 | 0 |
| 2020 | 20 | 0 |
| 2021 | 9 | 0 |
| 2022 | 16 | 0 |
| 2023 | 18 | 0 |
| 2024 | 13 | 0 |
| 2025 | 26 | 0 |
| 2026 | 13 | 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? (6)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K933743 | SSA-380ASummary page 1…ion of Predicate Devices: Toshiba America Medical Systems believes that this device is substantially equivalent to the SSA-380A/PowerVision 7000, 510(k) control numbers K933743,K943303, K963705, K964805,K970047, K981397 Device Description: The PowerVision 8000 Ultrasound System is a mobile system. This… | 1994 |
| * | K943303 | PVK-357ATSummary page 1…redicate Devices: Toshiba America Medical Systems believes that this device is substantially equivalent to the SSA-380A/PowerVision 7000, 510(k) control numbers K933743,K943303, K963705, K964805,K970047, K981397 Device Description: The PowerVision 8000 Ultrasound System is a mobile system. This system i… | 1995 |
| * | K963705 | Color Enhancement Function for the Ssa-380ASummary page 1…Devices: Toshiba America Medical Systems believes that this device is substantially equivalent to the SSA-380A/PowerVision 7000, 510(k) control numbers K933743,K943303, K963705, K964805,K970047, K981397 Device Description: The PowerVision 8000 Ultrasound System is a mobile system. This system is a Track… | 1996 |
| Kept off the family tree | K964805 | FDA’s K964805 is Bio-Anchor Our OCR of the scanned summary read K964805, FDA’s number for Bio-Anchor (Linvatec Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “SSA-380A/PowerVision 7000”. Kept off the family tree. Summary page 1…Toshiba America Medical Systems believes that this device is substantially equivalent to the SSA-380A/PowerVision 7000, 510(k) control numbers K933743,K943303, K963705, K964805,K970047, K981397 Device Description: The PowerVision 8000 Ultrasound System is a mobile system. This system is a Track 3 device… | 1997 |
| * | K970047 | Phased Array Transducer - - PSK-20CTSummary page 1…America Medical Systems believes that this device is substantially equivalent to the SSA-380A/PowerVision 7000, 510(k) control numbers K933743,K943303, K963705, K964805,K970047, K981397 Device Description: The PowerVision 8000 Ultrasound System is a mobile system. This system is a Track 3 device that em… | 1997 |
| * | K981397 | Harmonic Imaging and Flash Echo Imaging Function for the Diagnostic Ultrasound System…Summary page 1…Medical Systems believes that this device is substantially equivalent to the SSA-380A/PowerVision 7000, 510(k) control numbers K933743,K943303, K963705, K964805,K970047, K981397 Device Description: The PowerVision 8000 Ultrasound System is a mobile system. This system is a Track 3 device that employs a w… | 1998 |
What descends from it? (212)
See all 2121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013633 | Ssa-770A, Aplio Ultrasound System | 2001 | 211 |
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 10 years and passes through 1 company; a new generation was cleared every 2.3 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K013633 (Toshiba America Medical Systems, In.C, 2001) has gone furthest, with 211 descendants of its own.
- 6 other devices also cite its predicate K933743.
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 PowerVision 8000 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, 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/K991858 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991858: Ssa-390A/Power Vision 8000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991858
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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