510(k) Report

510(k) · Cleared

Cleared

Ultrasound Workstation, Uiws-300A

K982976510(k) TraditionalCleared Nov 24, 199890-day reviewClass II21 CFR 892.2050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Toshiba America Medical Systems, In.C · LLZ System, Image Processing, Radiological

Cleared on Nov 24, 1998 after a 90-day review. The FDA summary names its predicate without a number. 213 later devices descend from it.

Decided
Nov 24, 1998
Review
90 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
0

213 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2002: 1 descendant cleared2001: 1 descendant cleared2003: 1 descendant cleared2004: 1 descendant cleared2006: 1 descendant cleared2005: 2 descendants cleared2007: 3 descendants cleared2008: 5 descendants cleared2015: 5 descendants cleared2009: 5 descendants cleared2017: 12 descendants cleared2016: 7 descendants cleared2013: 4 descendants cleared2011: 4 descendants cleared2012: 8 descendants cleared2018: 18 descendants cleared2010: 1 descendant cleared2014: 10 descendants cleared2019: 8 descendants cleared2023: 18 descendants cleared2025: 26 descendants cleared2020: 20 descendants cleared2021: 9 descendants cleared2026: 13 descendants cleared2022: 16 descendants cleared2024: 13 descendants cleared1995200020052010201520202025
  1. This deviceK982976 Ultrasound Workstation, Uiws-300AToshiba America Medical Systems, In.C · 1998
  2. Descendant · cites it directly · 212 of its ownK992886 Powerview Ultrasound Workstation, Uidm-400AToshiba America Medical Systems, In.C · 1999
  3. Descendant · 2 generations on · 211 of its ownK013633 Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C · 2001
  4. Descendant · 2 generations on · 210 of its ownK022400 Ssa-700A, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2002 · Recalled
  5. Descendant · 3 generations on · 209 of its ownK032281 Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2003
  6. Descendant · 4 generations on · 205 of its ownK063130 Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0Toshibamedical Systems Corporation · 2006 · Recalled

Showing 5 of 213 descendants. See all descendants

Descendants cleared per year

1999: 12001: 12002: 12003: 12004: 12005: 22006: 12007: 32008: 52009: 52010: 12011: 42012: 82013: 42014: 102015: 52016: 72017: 122018: 182019: 82020: 202021: 92022: 162023: 182024: 132025: 262026: 13
1999high 26 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 213 · See all
  • K992886Powerview Ultrasound Workstation, Uidm-400AToshiba America Medical Systems, In.C · 1999 · cites it directly212descendants
  • K013633Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C · 2001 · 2 generations on211descendants
  • 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 · 3 generations on209descendants
  • K063130Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0Toshibamedical Systems Corporation · 2006 · 4 generations on205descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K982976Ultrasound Workstation, Uiws-300AToshiba America Medical Systems, In.C1998—
+1K992886Powerview Ultrasound Workstation, Uidm-400AToshiba America Medical Systems, In.C1999—
+2K013633Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C2001—
+2K022400Ssa-700A, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C20021
+3K032281Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2003—
+4K063130Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0Toshibamedical Systems Corporation20061

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200110
200210
200310
200410
200520
200610
200730
200850
200950
201010
201140
201280
201340
2014100
201550
201670
2017120
2018180
201980
2020200
202190
2022160
2023180
2024130
2025260
2026130
FIG. 1 — Lineage of K982976, 1998–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*—Nova MicroSonics, Image View DCR
Named without a submission number
—

What descends from it? (213)

See all 213

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K992886Powerview Ultrasound Workstation, Uidm-400AToshiba America Medical Systems, In.C1999212

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?

  • Of its descendants, K992886 (Toshiba America Medical Systems, In.C, 1999) has gone furthest, with 212 descendants of its own.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLZ

58in 2025

2007: 762008: 942009: 702010: 512011: 1062012: 822013: 952014: 782015: 642016: 822017: 782018: 1042019: 742020: 812021: 832022: 652023: 872024: 622025: 582026 (partial year): 45
2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007: 36 days median2008: 52 days median2009: 62 days median2010: 98 days median2011: 79 days median2012: 87 days median2013: 84 days median2014: 89 days median2015: 90 days median2016: 90 days median2017: 107 days median2018: 105 days median2019: 107 days median2020: 115 days median2021: 116 days median2022: 137 days median2023: 157 days median2024: 131 days median2025: 173 days median2026 (partial year): 110 days median
2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007: 202008: 322009: 212010: 172011: 302012: 122013: 642014: 62015: 162016: 122017: 52018: 72019: 22020: 62021: 32022: 42023: 82024: 62025: 112026 (partial year): 14
2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007: 1522008: 1542009: 1452010: 1452011: 4542012: 2662013: 1,1302014: 15,6312015: 2112016: 2902017: 1042018: 722019: 882020: 822021: 702022: 282023: 262024: 422025: 116
2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007763620152
2008945232154
2009706221145
2010519817145
20111067930454
2012828712266
20139584641,130
20147889615,631
2015649016211
2016829012290
2017781075104
2018104105772
201974107288
202081115682
202183116370
202265137428
202387157826
202462131642
20255817311116
20264511014—

What is it indicated for?

Retrieval and storage of both passive and active ultrasound images

Analysis of ultrasound images

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Toshiba America Medical Systems, In.C

146 FDA decisions under this applicant name. See the company

  • K141472Vantage ElanToshiba America Medical Systems, In.C · 2014
  • K133553KalareToshiba America Medical Systems, In.C · 20143 recalls
  • K140729Aplio Artida, V3.2Toshiba America Medical Systems, In.C · 2014
  • K132106Infinix Angio Workstation W/DTS SoftwareToshiba America Medical Systems, In.C · 2013
  • K131822Ultraextend Usws-900A V2.1 and V3.1Toshiba America Medical Systems, In.C · 2013

Recent decisions in LLZ

The LLZ category page

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  • K263048Syngo Carbon Space (VA4)Siemens Healthineers AG · 2026
  • K261874Syneris PACS v.1.0.1.0Syneris · 2026
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https://510kreport.com/device/K982976 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982976: Ultrasound Workstation, Uiws-300A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982976

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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