510(k) · Cleared
ClearedVitrea Software Package, VSTP-002A V2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canon Medical Systems Corporation · LLZ System, Image Processing, Radiological
Cleared on Jul 17, 2024 as substantially equivalent to K223336 (Canon Medical Systems Corporation, 2023) after a 125-day review. Its family tree reaches back 19 generations to 1991.
- Decided
- Jul 17, 2024
- Review
- 125 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 19 generations to K913770 (1991). 190 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet.
- Root · 19 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 15 generations between
- 3 generations backK203312 Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2021
- 2 generations backK213504 Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System…Canon Medical Systems Corporation · 2022
- 1 generation backK223336 Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation · 2023
- This deviceK240705 Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation · 2024
Show all 19 generations
- Root · 19 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 18 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 17 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 16 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 15 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 14 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 13 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 12 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 11 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 10 generations backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- 9 generations backK073156 Qplaque MRMedis Medical Imaging Systems BV · 2008
- 8 generations backK120636 Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012
- 7 generations backK171222 Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation · 2017
- 6 generations backK173088 Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation · 2018
- 5 generations backK183013 Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2018
- 4 generations backK192923 Vitrea Software PackageCanon Medical Systems Corporation · 2020
- 3 generations backK203312 Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2021
- 2 generations backK213504 Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System…Canon Medical Systems Corporation · 2022
- 1 generation backK223336 Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation · 2023
- This deviceK240705 Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −18 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −17 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −16 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −15 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −14 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −13 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −12 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −11 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| −10 | K071331 | Vitrea Version 4.0 | Vital Images, Inc. | 2007 | 1 |
| −9 | K073156 | Qplaque MR | Medis Medical Imaging Systems BV | 2008 | — |
| −8 | K120636 | Synapse 3D Cardiac Tools | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
| −7 | K171222 | Vitrea Software Toshiba Package; VSTP-001A | Toshibamedical Systems Corporation | 2017 | — |
| −6 | K173088 | Vitrea Software Toshiba Package VSTP-001A | Toshibamedical Systems Corporation | 2018 | — |
| −5 | K183013 | Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | 2018 | — |
| −4 | K192923 | Vitrea Software Package | Canon Medical Systems Corporation | 2020 | — |
| −3 | K203312 | Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | 2021 | — |
| −2 | K213504 | Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software… | Canon Medical Systems Corporation | 2022 | — |
| −1 | K223336 | Vitrea Software Package, VSTP-002A | Canon Medical Systems Corporation | 2023 | — |
| 0 (this device) | K240705 | Vitrea Software Package, VSTP-002A V2.0 | 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 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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 21.6 · 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? (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.
What descends from it?
No later submission names this one as a predicate yet.
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 33 years and passes through 8 companies; a new generation was cleared every 11 months on median.
- 59 of the 190 ancestors have a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 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 Software Package has the following additional indications: Auto MPR Brain application is a post processing software of CT brain images that is intended to align images into a…
Read the full statement (126 words)
Vitrea Software 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 Software Package has the following additional indications:
Auto MPR Brain application is a post processing software of CT brain images that is intended to align images into a standard anatomical position for review. It provides tools to reformat images parallel to a standard anatomical position.
Subtraction Viewer is a viewer application that is intended for viewing original, subtraction and fusion CT images, but such subtraction processing is not a part of this application. This application supports fusion display of original image and subtraction image generated by other applications.
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/K240705 · printed Nov 3, 2026
Cite this page
510(k) Report. “K240705: Vitrea Software Package, VSTP-002A V2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K240705
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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