510(k) · Cleared
ClearedSSA-380A
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 Oct 20, 1994 after a 443-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 748 devices in its family, counting itself, have a Class I recall. 747 later devices descend from it.
- Decided
- Oct 20, 1994
- Review
- 443 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 0
747 later devices descend from it, 7 citing it directly. 3 of the 748 devices in this family, counting this one, have a Class I recall.
- This deviceK933743 SSA-380AToshiba America Medical Systems, In.C · 1994
- Descendant · cites it directly · 403 of its ownK970047 Phased Array Transducer - - PSK-20CTToshiba America Medical Systems, In.C · 1997
- Descendant · cites it directly · 403 of its ownK963705 Color Enhancement Function for the Ssa-380AToshiba America Medical Systems, In.C · 1996
- Descendant · cites it directly · 212 of its ownK991858 Ssa-390A/Power Vision 8000Toshiba America Medical Systems, In.C · 1999
- Descendant · 2 generations on · 211 of its ownK013633 Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C · 2001
- Descendant · cites it directly · 211 of its ownK974813 Combison 530D with Power Doppler ModeMedison America, Inc. · 1998
Showing 5 of 747 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 747 · See all- K970047Phased Array Transducer - - PSK-20CTToshiba America Medical Systems, In.C · 1997 · cites it directly403descendants
- K963705Color Enhancement Function for the Ssa-380AToshiba America Medical Systems, In.C · 1996 · cites it directly403descendants
- K991858Ssa-390A/Power Vision 8000Toshiba America Medical Systems, In.C · 1999 · cites it directly212descendants
- K013633Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C · 2001 · 2 generations on211descendants
- K974813Combison 530D with Power Doppler ModeMedison America, Inc. · 1998 · cites it directly211descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K933743 | SSA-380A | Toshiba America Medical Systems, In.C | 1994 | — |
| +1 | K970047 | Phased Array Transducer - - PSK-20CT | Toshiba America Medical Systems, In.C | 1997 | — |
| +1 | K963705 | Color Enhancement Function for the Ssa-380A | Toshiba America Medical Systems, In.C | 1996 | — |
| +1 | K991858 | Ssa-390A/Power Vision 8000 | Toshiba America Medical Systems, In.C | 1999 | — |
| +2 | K013633 | Ssa-770A, Aplio Ultrasound System | Toshiba America Medical Systems, In.C | 2001 | — |
| +1 | K974813 | Combison 530D with Power Doppler Mode | Medison America, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 8 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 7 | 0 |
| 2006 | 7 | 0 |
| 2007 | 11 | 0 |
| 2008 | 14 | 0 |
| 2009 | 19 | 0 |
| 2010 | 15 | 0 |
| 2011 | 22 | 0 |
| 2012 | 21 | 0 |
| 2013 | 22 | 0 |
| 2014 | 29 | 0 |
| 2015 | 35 | 0 |
| 2016 | 38 | 0 |
| 2017 | 57 | 0 |
| 2018 | 52 | 0 |
| 2019 | 41 | 0 |
| 2020 | 52 | 1 |
| 2021 | 42 | 0 |
| 2022 | 45 | 0 |
| 2023 | 44 | 0 |
| 2024 | 42 | 0 |
| 2025 | 63 | 2 |
| 2026 | 41 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 devices in this family have a Class I recall. 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (747)
See all 7477 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K970047 | Phased Array Transducer - - PSK-20CT | 1997 | 403 |
| K963705 | Color Enhancement Function for the Ssa-380A | 1996 | 403 |
| K991858 | Ssa-390A/Power Vision 8000 | 1999 | 212 |
| K974813 | Combison 530D with Power Doppler Mode | 1998 | 211 |
| K964865 | PVK-720ST Endocavitary Transducer | 1997 | 204 |
| K991710 | Ssa-370A/Powervision 6000 | 1999 | 203 |
| K954028 | HP Sonos Ultrasound Imaging System | 1996 | 192 |
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K193517ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · 8 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 10 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
- K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 10 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K970047 (Toshiba America Medical Systems, In.C, 1997) has gone furthest, with 403 descendants of its own.
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) | — |
https://510kreport.com/device/K933743 · printed Nov 6, 2026
Cite this page
510(k) Report. “K933743: SSA-380A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933743
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026