510(k) · Cleared
ClearedPowerview Ultrasound Workstation, Uidm-400A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshiba America Medical Systems, In.C · LLZ System, Image Processing, Radiological
Cleared on Nov 9, 1999 as substantially equivalent to K982976 (Toshiba America Medical Systems, In.C, 1998) and 2 other predicates after a 75-day review. Its family tree reaches back 3 generations to 1994. 212 later devices descend from it.
- Decided
- Nov 9, 1999
- Review
- 75 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K930768 (1994). 8 ancestors in all. 212 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK930768 Orion Diagnostic Ultrasound SystemGE Medical Systems · 1994
- 2 generations backK964617 GE Logiq 700 Diagnostic Ultrasound SystemGE Medical Systems · 1997
- 1 generation backK990248 Dicom Image Manager, Model 3-D Visualization OptionDicomit Imaging Systems Corp. · 1999
- This deviceK992886 Powerview Ultrasound Workstation, Uidm-400AToshiba 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 · cites it directly · 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 · cites it directly210descendants
- 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 | K930768 | Orion Diagnostic Ultrasound System | GE Medical Systems | 1994 | — |
| −2 | K964617 | GE Logiq 700 Diagnostic Ultrasound System | GE Medical Systems | 1997 | — |
| −1 | K990248 | Dicom Image Manager, Model 3-D Visualization Option | Dicomit Imaging Systems Corp. | 1999 | — |
| 0 (this device) | K992886 | Powerview Ultrasound Workstation, Uidm-400A | Toshiba America Medical Systems, In.C | 1999 | — |
| +1 | K013633 | Ssa-770A, Aplio Ultrasound System | Toshiba America Medical Systems, In.C | 2001 | — |
| +1 | 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 |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K982976 | Ultrasound Workstation, Uiws-300ASummary page 1…2020563 PowerView Ultrasound Workstation, UIDM-400A Picture Archiving and Communications System Class II per 21 CFR § 892.2050; 90LLZ Toshiba Workstation, UTWS-300A (K982976) Dicomit Image Manager (K990248) Tomtec Echo-Scan (K963807) Reason For Submission New Product Description of this Device: The UI… | 1998 |
| * | K990248 | Dicom Image Manager, Model 3-D Visualization OptionSummary page 1…kstation, UIDM-400A Picture Archiving and Communications System Class II per 21 CFR § 892.2050; 90LLZ Toshiba Workstation, UTWS-300A (K982976) Dicomit Image Manager (K990248) Tomtec Echo-Scan (K963807) Reason For Submission New Product Description of this Device: The UIDM-400A, PowerView Ultrasound Wor… | 1999 |
| * | K963807 | Tomtec Echo-ScanSummary page 1…e Archiving and Communications System Class II per 21 CFR § 892.2050; 90LLZ Toshiba Workstation, UTWS-300A (K982976) Dicomit Image Manager (K990248) Tomtec Echo-Scan (K963807) Reason For Submission New Product Description of this Device: The UIDM-400A, PowerView Ultrasound Workstation, is an all digital… | 1996 |
What descends from it? (212)
See all 2122 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 5 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K013633 (Toshiba America Medical Systems, In.C, 2001) has gone furthest, with 211 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
Retrieval and storage of both passive and active ultrasound images.
Analysis of ultrasound images
Reconstruction and display of three dimensional images.
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/K992886 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992886: Powerview Ultrasound Workstation, Uidm-400A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992886
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