510(k) · Cleared
ClearedVirtue
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnosoft, Inc. · LLZ System, Image Processing, Radiological
Cleared on Sep 21, 2011 as substantially equivalent to K023137 (Philips Medical Systems North America Co., 2002) and 1 other predicate after an 85-day review. Its family tree reaches back 4 generations to 1990. 4 later devices descend from it.
- Decided
- Sep 21, 2011
- Review
- 85 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K900889 (1990). 6 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK900889 Magnetic Resonance Diagnostic Device AccessoriesSiemens Medical Solutions USA, Inc. · 1990
- 3 generations backK973799 Cardiac Tagging Techniques/Magnetom Vision and Magnetom ImpactSiemens Medical Solutions USA, Inc. · 1998
- 2 generations backK061368 Diagnosoft HarpDiagnosoft, Inc. · 2006
- 1 generation backK100352 Diagnosoft Harp Model 2.06Diagnosoft, Inc. · 2010
- This deviceK111833 VirtueDiagnosoft, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK163076 Segment CMRMedviso AB · 2017
- Descendant · 2 generations on · 0 of its ownK232007 CAAS MR SolutionsPie Medical Imaging BV · 2024
- Descendant · 2 generations on · 0 of its ownK211611 QIR SuiteCasis Cardiac Simulation & Imaging Software · 2022
- Descendant · cites it directly · 0 of its ownK131158 CorviewMarrek, Inc. · 2013
Most influential descendants
Showing 4 of 4 · See all- K163076Segment CMRMedviso AB · 2017 · cites it directly2descendants
- K232007CAAS MR SolutionsPie Medical Imaging BV · 2024 · 2 generations on0descendants
- K211611QIR SuiteCasis Cardiac Simulation & Imaging Software · 2022 · 2 generations on0descendants
- K131158CorviewMarrek, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K900889 | Magnetic Resonance Diagnostic Device Accessories | Siemens Medical Solutions USA, Inc. | 1990 | — |
| −3 | K973799 | Cardiac Tagging Techniques/Magnetom Vision and Magnetom Impact | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −2 | K061368 | Diagnosoft Harp | Diagnosoft, Inc. | 2006 | — |
| −1 | K100352 | Diagnosoft Harp Model 2.06 | Diagnosoft, Inc. | 2010 | — |
| 0 (this device) | K111833 | Virtue | Diagnosoft, Inc. | 2011 | — |
| +1 | K163076 | Segment CMR | Medviso AB | 2017 | — |
| +2 | K232007 | CAAS MR Solutions | Pie Medical Imaging BV | 2024 | — |
| +2 | K211611 | QIR Suite | Casis Cardiac Simulation & Imaging Software | 2022 | — |
| +1 | K131158 | Corview | Marrek, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K023137 | Philips Easyvision Workstation Release 6Summary page 1…Name: Picture archiving and communications system 3. PREDICATE DEVICE *Philips Easy Vision Workstation Release 6 marketed by Philips Medical Systems, K023 137 *Har 2.06 marketed by Diagnosot't, Inc., K100352 4. DEVICE DESCRIPTION The Diagnosoft Virtue is software that runs o… | 2002 |
| * | K100352 | Diagnosoft Harp Model 2.06Summary page 1…3. PREDICATE DEVICE *Philips Easy Vision Workstation Release 6 marketed by Philips Medical Systems, K023 137 *Har 2.06 marketed by Diagnosot't, Inc., K100352 4. DEVICE DESCRIPTION The Diagnosoft Virtue is software that runs on Windows-based operating systems to view and analyze M… | 2010 |
What descends from it? (4)
2 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 21 years and passes through 2 companies; a new generation was cleared every 7.8 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K163076 (Medviso AB, 2017) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K023137.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The Virtue software receives image data from medical scanning devices, such as CT or MRI, or from image archives and performs viewing, image manipulation, communication, printing and quantification of images.
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/K111833 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111833: Virtue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111833
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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