510(k) · Cleared
ClearedModel SSH-140A Ultrasound Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshiba America Medical Systems, In.C · DXK Echocardiograph
Cleared on Oct 19, 1989 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 406 devices in its family, counting itself, have a Class I recall. 405 later devices descend from it.
- Decided
- Oct 19, 1989
- Review
- 87 days
- Class
- Class II
- Product code
- DXK
- Recalls
- None
- Predicates
- 0
405 later devices descend from it, 1 citing it directly. 3 of the 406 devices in this family, counting this one, have a Class I recall.
- This deviceK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- Descendant · cites it directly · 404 of its ownK941593 Diagnostic Ultrasonic TransducerToshiba America Medical Systems, In.C · 1996
- Descendant · 2 generations on · 403 of its ownK970047 Phased Array Transducer - - PSK-20CTToshiba America Medical Systems, In.C · 1997
- Descendant · 3 generations on · 212 of its ownK991858 Ssa-390A/Power Vision 8000Toshiba America Medical Systems, In.C · 1999
- Descendant · 4 generations on · 211 of its ownK013633 Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C · 2001
- Descendant · 5 generations on · 210 of its ownK022400 Ssa-700A, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2002 · Recalled
Showing 5 of 405 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 405 · See all- K941593Diagnostic Ultrasonic TransducerToshiba America Medical Systems, In.C · 1996 · cites it directly404descendants
- K970047Phased Array Transducer - - PSK-20CTToshiba America Medical Systems, In.C · 1997 · 2 generations on403descendants
- K991858Ssa-390A/Power Vision 8000Toshiba America Medical Systems, In.C · 1999 · 3 generations on212descendants
- K013633Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C · 2001 · 4 generations on211descendants
- K022400Ssa-700A, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2002 · 5 generations on210descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K894632 | Model SSH-140A Ultrasound Imaging System | Toshiba America Medical Systems, In.C | 1989 | — |
| +1 | K941593 | Diagnostic Ultrasonic Transducer | Toshiba America Medical Systems, In.C | 1996 | — |
| +2 | K970047 | Phased Array Transducer - - PSK-20CT | Toshiba America Medical Systems, In.C | 1997 | — |
| +3 | K991858 | Ssa-390A/Power Vision 8000 | Toshiba America Medical Systems, In.C | 1999 | — |
| +4 | K013633 | Ssa-770A, Aplio Ultrasound System | Toshiba America Medical Systems, In.C | 2001 | — |
| +5 | K022400 | Ssa-700A, Aplio Diagnostic Ultrasound System | Toshiba America Medical Systems, In.C | 2002 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 7 | 0 |
| 2008 | 6 | 0 |
| 2009 | 11 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 12 | 0 |
| 2013 | 6 | 0 |
| 2014 | 18 | 0 |
| 2015 | 13 | 0 |
| 2016 | 18 | 0 |
| 2017 | 22 | 0 |
| 2018 | 28 | 0 |
| 2019 | 18 | 0 |
| 2020 | 35 | 1 |
| 2021 | 24 | 0 |
| 2022 | 28 | 0 |
| 2023 | 30 | 0 |
| 2024 | 25 | 0 |
| 2025 | 48 | 2 |
| 2026 | 32 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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? (405)
See all 4051 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K941593 | Diagnostic Ultrasonic Transducer | 1996 | 404 |
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 · 10 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 12 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
- K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 12 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K941593 (Toshiba America Medical Systems, In.C, 1996) has gone furthest, with 404 descendants of its own.
How does its category compare?
All DXK devicesDXK Echocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXK
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · DXK
Too few DXK 510(k)s in any year since 2007 to give a median.
Recalls per year · DXK
No recall names DXK since 2007.
Adverse event reports per year · DXK
1in 2024
MAUDE reports naming product code DXK, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K894632 · printed Nov 4, 2026
Cite this page
510(k) Report. “K894632: Model SSH-140A Ultrasound Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K894632
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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