510(k) · Cleared
ClearedVitrea Software Package, VSTP-001A
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 Dec 14, 2018 as substantially equivalent to K151091 (Toshibamedical Systems Corporation, 2015) and 5 other predicates after an 84-day review. Its family tree reaches back 14 generations to 1991.
- Decided
- Dec 14, 2018
- Review
- 84 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 14 generations to K913770 (1991). 217 ancestors in all, the oldest K837107 (1983). No later device cites it as a predicate yet.
- Root · 14 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 10 generations between
- 3 generations backK120636 Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012
- 2 generations backK171222 Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation · 2017
- 1 generation backK173088 Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation · 2018
- This deviceK182601 Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2018
Show all 14 generations
- Root · 14 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 13 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 12 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 11 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 10 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 9 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 8 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 7 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 6 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 5 generations backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- 4 generations backK073156 Qplaque MRMedis Medical Imaging Systems BV · 2008
- 3 generations backK120636 Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012
- 2 generations backK171222 Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation · 2017
- 1 generation backK173088 Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation · 2018
- This deviceK182601 Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −13 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −12 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −11 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −10 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −9 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −8 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −7 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −6 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| −5 | K071331 | Vitrea Version 4.0 | Vital Images, Inc. | 2007 | 1 |
| −4 | K073156 | Qplaque MR | Medis Medical Imaging Systems BV | 2008 | — |
| −3 | K120636 | Synapse 3D Cardiac Tools | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
| −2 | K171222 | Vitrea Software Toshiba Package; VSTP-001A | Toshibamedical Systems Corporation | 2017 | — |
| −1 | K173088 | Vitrea Software Toshiba Package VSTP-001A | Toshibamedical Systems Corporation | 2018 | — |
| 0 (this device) | K182601 | Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 4 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 8 | 0 |
| 1997 | 6 | 0 |
| 1998 | 11 | 0 |
| 1999 | 6 | 0 |
| 2000 | 13 | 0 |
| 2001 | 20 | 0 |
| 2002 | 18 | 0 |
| 2003 | 17 | 0 |
| 2004 | 17 | 0 |
| 2005 | 13 | 0 |
| 2006 | 12 | 0 |
| 2007 | 6 | 0 |
| 2008 | 4 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2018 | 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? (6)
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-001A Our reading of the summary gave K151093, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “VSTP-001A”. | 2015 |
| * | K171222 | Vitrea Software Toshiba Package; VSTP-001ASummary page 5…Cleared (CT/XA Cerebral Artery Morphological Analysis) MR Coronary Tracking VSTP-001A K171222 Cleared SURE Volume Synthesis VSTP-001A K173088… | 2017 |
| * | K173088 | Vitrea Software Toshiba Package VSTP-001ASummary page 5…ry Tracking VSTP-001A K171222 Cleared SURE Volume Synthesis VSTP-001A K173088 Cleared 2441 Michelle Drive, Tustin, CA 92780 PHONE: 800-421-1968 https://us.medical.canon… | 2018 |
| * | K180323 | Vitrea Software Package; VSTP-001ASummary page 6…US Cardiac Fusion VSTP-001A K173088 Cleared Ultrasound Application Package VSTP-001A K180323 Cleared Application Predicate 510(K) Status… | 2018 |
| * | K132813 | Dual Energy System PackageSummary page 6…s Control # Dual Energy Stone Analysis Canon Aquilion K132813 New Dual Energy Composition Canon Aquilion K132813 New Ana… | 2014 |
| * | K142273 | EmboGuideSummary page 6…l Energy Composition Canon Aquilion K132813 New Analysis Embolization Planning Tool Philips K142273 New EmboGuide Primary Predicate Device:… | 2015 |
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 27 years and passes through 8 companies; a new generation was cleared every 11 months on median.
- 66 of the 217 ancestors have a recall of any class.
- 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 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 multidimensional digital images acquired from a variety of imaging devices. Vitrea has the following indications: The Cerebral Aneurysm Analysis application is intended to facilitate the extraction and segmentation of user identified aneurysms on the cerebral…
Read the full statement (415 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 multidimensional digital images acquired from a variety of imaging devices. Vitrea has the following indications:
The Cerebral Aneurysm 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.
The Ultrasound Clinical Applications are indicated for the visualization of structures, and dynamic processes with the human body using saved ultrasound DICOM images to provide image information for diagnosis.
The DE Stone Analysis application is intended to serve as an adjunct visualization tool for the differentiation between uric acid and non-uric acid stones greater than 3mm with Dual Energy CT studies.
The DE Composition Analysis application is intended to serve as an adjunct visualization tool for the uric acid presence within surrounding anatomical structures with Dual Energy CT studies.
Embolization Plan is a post processing software that is intended to assist physicians in the visualization of the liver arterial tree using 3D images of CT or 3D images of Cone Beam CT (INFX-8000 Interventional Family) acquired by Toshiba or Canon Medical Systems. It provides tools to assist the user in analysis of these images. The output is intended to be an adjunct means that allows automatic and manual planning of the liver arterial vessels for guidance of the embolization procedure. The output is a 3D visualization of the hepatic arteries to high dense lesion in the liver.
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/K182601 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182601: Vitrea Software Package, VSTP-001A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182601
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