510(k) · Cleared
ClearedVitrea Software Toshiba Package VSTP-001A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshibamedical Systems Corporation · LLZ System, Image Processing, Radiological
Cleared on Jan 31, 2018 as substantially equivalent to K151091 (Toshibamedical Systems Corporation, 2015) and 4 other predicates after a 124-day review. Its family tree reaches back 13 generations to 1991. 11 later devices descend from it.
- Decided
- Jan 31, 2018
- Review
- 124 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 13 generations to K913770 (1991). 175 ancestors in all, the oldest K871859 (1987). 11 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 9 generations between
- 3 generations backK073156 Qplaque MRMedis Medical Imaging Systems BV · 2008
- 2 generations backK120636 Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012
- 1 generation backK171222 Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation · 2017
- This deviceK173088 Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation · 2018
- Descendant · cites it directly · 9 of its ownK183013 Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2018
- Descendant · 2 generations on · 8 of its ownK192923 Vitrea Software PackageCanon Medical Systems Corporation · 2020
- Descendant · 3 generations on · 7 of its ownK203312 Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2021
- Descendant · 4 generations on · 6 of its ownK213504 Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System…Canon Medical Systems Corporation · 2022
- Descendant · 5 generations on · 3 of its ownK232835 Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation · 2024
Show all 13 generations
- Root · 13 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 12 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 11 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 10 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 9 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 8 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 7 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 6 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 5 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 4 generations backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- 3 generations backK073156 Qplaque MRMedis Medical Imaging Systems BV · 2008
- 2 generations backK120636 Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012
- 1 generation backK171222 Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation · 2017
- This deviceK173088 Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation · 2018
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2018 · cites it directly9descendants
- K192923Vitrea Software PackageCanon Medical Systems Corporation · 2020 · 2 generations on8descendants
- K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2021 · 3 generations on7descendants
- K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation · 2022 · 4 generations on6descendants
- K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation · 2024 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −12 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −11 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −10 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −9 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −8 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −7 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −6 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −5 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| −4 | K071331 | Vitrea Version 4.0 | Vital Images, Inc. | 2007 | 1 |
| −3 | K073156 | Qplaque MR | Medis Medical Imaging Systems BV | 2008 | — |
| −2 | K120636 | Synapse 3D Cardiac Tools | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
| −1 | K171222 | Vitrea Software Toshiba Package; VSTP-001A | Toshibamedical Systems Corporation | 2017 | — |
| 0 (this device) | K173088 | Vitrea Software Toshiba Package VSTP-001A | Toshibamedical Systems Corporation | 2018 | — |
| +1 | K183013 | Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | 2018 | — |
| +2 | K192923 | Vitrea Software Package | Canon Medical Systems Corporation | 2020 | — |
| +3 | K203312 | Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | 2021 | — |
| +4 | K213504 | Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software… | Canon Medical Systems Corporation | 2022 | — |
| +5 | K232835 | Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System | Canon Medical Systems Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 4 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 6 | 0 |
| 1997 | 6 | 0 |
| 1998 | 8 | 0 |
| 1999 | 5 | 0 |
| 2000 | 12 | 0 |
| 2001 | 17 | 0 |
| 2002 | 17 | 0 |
| 2003 | 15 | 0 |
| 2004 | 13 | 0 |
| 2005 | 9 | 0 |
| 2006 | 8 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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? (5)
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 |
|---|---|---|---|
| * | K151091 | Vitrea Software Toshiba Package, VSTP-001ASummary page 5…Status Control# Product Code MR Wall Motion VSTP-001A K151091 21 CFR 892.2050 Cleared Tracking 90LLZ CT/XA Cerebral A… | 2015 |
| * | K171222 | Vitrea Software Toshiba Package; VSTP-001ASummary page 5…K151091 21 CFR 892.2050 Cleared Morphological Analysis 90LLZ MR Coronary Tracking VSTP-001A K171222 21 CFR 892.2050 Cleared 90LLZ SURE Vo… | 2017 |
| * | K101228 | Mirada XDSummary page 5…171222 21 CFR 892.2050 Cleared 90LLZ SURE Volume Synthesis Miranda XD K101228 21 CFR 892.2050 New 90LLZ Angio Viewer… | 2010 |
| * | K081624 | Infx-8000F (Infinix Csi and Infinix Dpi)Summary page 5…a XD K101228 21 CFR 892.2050 New 90LLZ Angio Viewer Toshiba K081624 New INFX-8000F US Cardiac Fusion GE CardIQ K061370… | 2008 |
| * | K061370 | Cardiq FusionSummary page 5…ngio Viewer Toshiba K081624 New INFX-8000F US Cardiac Fusion GE CardIQ K061370 21 CFR 892.2050 New Fusion 90LLZ 12. REASON FOR SUBM… | 2006 |
What descends from it? (11)
See all 112 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 27 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 57 of the 175 ancestors have a recall of any class.
- Of its descendants, K183013 (Canon Medical Systems Corporation, 2018) has gone furthest, with 9 descendants of its own.
- 3 other devices also cite its predicate K151091.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
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?
Vitrea Software Toshiba Package is an application package developed for use on Vitrea®, a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea has the following additional indications: The CT/XA Cerebral Artery Morphological Analysis application is intended to facilitate the extraction and segmentation of user…
Read the full statement (232 words)
Vitrea Software Toshiba Package is an application package developed for use on Vitrea®, a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea has the following additional indications:
The CT/XA Cerebral Artery Morphological Analysis application is intended to facilitate the extraction and segmentation of user identified aneurysms on the cerebral arteries. The software can be used as an adjunct to diagnosis for the purposes of measurement of size and aspect ratio.
The MR Wall Motion Tracking application is intended to assist physicians with performing cardiac functional analysis based upon magnetic resonance images. It provides measurements of global and regional myocardial function that is used for patients with suspected heart disease.
The MR Coronary Tracking application is intended to assist physicians with performing coronary artery analysis for MR heart images which are intended for the qualitative and quantitative analysis of coronary arteries.
The SUREVolume Synthesis application is intended to load volume images acquired by whole-body X-ray CT scanners, X-ray angiography systems, and MRI systems and displays fusion images.
The Angio Viewer application displays image data acquired using an X-ray angiography system. It supports cine display, subtraction, and distance measurement.
The US Cardiac Fusion application enables fusion display of the analysis results obtained using the US 3D Wall Motion Tracking application and the CT Coronary Artery Analysis application.
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/K173088 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173088: Vitrea Software Toshiba Package VSTP-001A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173088
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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