510(k) · Cleared
ClearedVITREA2 Version 3.5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vital Images, Inc. · LLZ System, Image Processing, Radiological
Cleared on Feb 24, 2004 as substantially equivalent to K032748 (Vital Images, Inc., 2003) and 1 other predicate after a 15-day review. Its family tree reaches back 5 generations to 1991. 164 later devices descend from it.
- Decided
- Feb 24, 2004
- Review
- 15 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K913770 (1991). 18 ancestors in all. 164 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 4 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 3 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 2 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 1 generation backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- This deviceK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- Descendant · cites it directly · 143 of its ownK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 117 of its ownK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 111 of its ownK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- Descendant · 4 generations on · 82 of its ownK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- Descendant · 5 generations on · 21 of its ownK073156 Qplaque MRMedis Medical Imaging Systems BV · 2008
Showing 5 of 164 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 164 · See all- K043333VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · cites it directly143descendants
- K052632VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · 2 generations on117descendants
- K061624Vitrea, Version 3.9Vital Images, Inc. · 2006 · 3 generations on111descendants
- K071331Vitrea Version 4.0Vital Images, Inc. · 2007 · 4 generations on82descendants
- K073156Qplaque MRMedis Medical Imaging Systems BV · 2008 · 5 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −4 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −3 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −2 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −1 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| 0 (this device) | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| +1 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| +2 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| +3 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| +4 | K071331 | Vitrea Version 4.0 | Vital Images, Inc. | 2007 | 1 |
| +5 | K073156 | Qplaque MR | Medis Medical Imaging Systems BV | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 6 | 0 |
| 2008 | 5 | 0 |
| 2009 | 7 | 0 |
| 2011 | 2 | 0 |
| 2012 | 12 | 0 |
| 2013 | 3 | 0 |
| 2014 | 8 | 0 |
| 2015 | 8 | 0 |
| 2016 | 6 | 0 |
| 2017 | 8 | 0 |
| 2018 | 10 | 0 |
| 2019 | 4 | 0 |
| 2020 | 6 | 0 |
| 2021 | 8 | 0 |
| 2022 | 10 | 0 |
| 2023 | 9 | 0 |
| 2024 | 16 | 0 |
| 2025 | 19 | 0 |
| 2026 | 11 | 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? (2)
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 |
|---|---|---|---|
| * | K032748 | VITREA2, Version 3.4 Medical Image Processing SoftwareSummary page 1…Image Processing, Radiological Name Classification Name LLZ, Class II, CFR 21 892.2050 Vitrea 2, Version 3.4 (K032748) Vital Images, Inc. Predicate Devices Fusion7D (K0… | 2003 |
| * | K020546 | Fusion 7DSummary page 1…Vitrea 2, Version 3.4 (K032748) Vital Images, Inc. Predicate Devices Fusion7D (K020546) Mirada Solutions, Ltd. Device Description The Vitrea 2 system is a medical diagnostic… | 2002 |
What descends from it? (164)
See all 1643 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 13 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 4 of the 18 ancestors have a recall of any class.
- Of its descendants, K043333 (Vital Images, Inc., 2004) has gone furthest, with 143 descendants of its own.
- 3 other devices also cite its predicate K032748.
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?
Vitrea 2 is 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. In addition, the Vitrea 2 system has the following specific indication: Fusion7D is an option within the Vitrea 2 system and is intended to register pairs of anatomical and functional volumetric images (e.g., MRI-SPECT, MRI-PET, CT-SPECT, CT-PET), or pairs…
Read the full statement (232 words)
Vitrea 2 is 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. In addition, the Vitrea 2 system has the following specific indication:
Fusion7D is an option within the Vitrea 2 system and is intended to register pairs of anatomical and functional volumetric images (e.g., MRI-SPECT, MRI-PET, CT-SPECT, CT-PET), or pairs of anatomical volumetric images (e.g., MRI-MRI, CT-CT, and MRI-CT) as a means to ease the comparison of image data. The result of the registration operations aims to help the clinician obtain a better understanding of the joint information that would otherwise have to be compared separately. This is useful for a wide range of clinical and therapeutic applications. It is important to note that the clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard procedures, including visual comparison of the separate unregistered images. Fusion7D is a complement to these standard procedures.
Softread, is an option within the Vitrea 2 system and is intended to allow the examination and manipulation of a series of 2D images in a variety of modalities, including CT, MR, CR/DRIDX, SC, US, NM, PET, XA, and RF, etc. The option also enables clinicians to compare multiple series' for the same patient, side-by-side, and to switch to Vitrea to further examine the data in a 3D volume.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040305 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040305: VITREA2 Version 3.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040305
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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