510(k) · Cleared
ClearedVitrea CT Myocardial Analysis
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 Nov 18, 2011 as substantially equivalent to K073138 (GE Medical Systems, 2008) and 1 other predicate after a 79-day review. Its family tree reaches back 8 generations to 1997. 6 later devices descend from it.
- Decided
- Nov 18, 2011
- Review
- 79 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K971684 (1997). 31 ancestors in all, the oldest K913770 (1991). 6 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 7 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 6 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 5 generations backK052423 Magnetom Systems with Syngo Expert - I OptionSiemens Medi Cal Solutions, Inc. · 2006
- 4 generations backK061964 Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2006
- 3 generations backK072728 Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2008
- 2 generations backK092519 Syngo.XSiemens AG Medical Solutions · 2009 · Recalled
- 1 generation backK110366 Syngo.CT Cardiac FunctionSiemens AG · 2011 · Recalled
- This deviceK112531 Vitrea CT Myocardial AnalysisVital Images, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK151212 Ziostation2Qi Imaging, LLC · 2015
- Descendant · 2 generations on · 1 of its ownK181892 Ziostation2Ziosoft, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK132523 MyoperfusionToshibamedical Systems Corporation · 2013 · Recalled
- Descendant · cites it directly · 0 of its ownK201250 SQuEEZ SoftwareCardiowise, Inc. · 2020
- Descendant · 3 generations on · 0 of its ownK200315 Ziostation2Ziosoft, Inc. · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K151212Ziostation2Qi Imaging, LLC · 2015 · cites it directly2descendants
- K181892Ziostation2Ziosoft, Inc. · 2018 · 2 generations on1descendant
- K132523MyoperfusionToshibamedical Systems Corporation · 2013 · cites it directly1descendant
- K201250SQuEEZ SoftwareCardiowise, Inc. · 2020 · cites it directly0descendants
- K200315Ziostation2Ziosoft, Inc. · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −7 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −6 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −5 | K052423 | Magnetom Systems with Syngo Expert - I Option | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −4 | K061964 | Syngo Multimodality Workplace | Siemens AG Medical Solutions | 2006 | — |
| −3 | K072728 | Syngo Multimodality Workplace | Siemens AG Medical Solutions | 2008 | — |
| −2 | K092519 | Syngo.X | Siemens AG Medical Solutions | 2009 | 4 |
| −1 | K110366 | Syngo.CT Cardiac Function | Siemens AG | 2011 | 1 |
| 0 (this device) | K112531 | Vitrea CT Myocardial Analysis | Vital Images, Inc. | 2011 | — |
| +1 | K151212 | Ziostation2 | Qi Imaging, LLC | 2015 | — |
| +2 | K181892 | Ziostation2 | Ziosoft, Inc. | 2018 | — |
| +1 | K132523 | Myoperfusion | Toshibamedical Systems Corporation | 2013 | 1 |
| +1 | K201250 | SQuEEZ Software | Cardiowise, Inc. | 2020 | — |
| +3 | K200315 | Ziostation2 | Ziosoft, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 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 |
|---|---|---|---|
| * | K073138 | Cardiq Express Version 2.0Summary page 1…ications System Classification Name: System, Image Processing, Radiological (21 C.F.R. 892.2050, LLZ) Predicate Devices: GE Medical Systems CardlQ Express Version 2.0 (K073138) Siemens AG syngo.CT Cardiac Functions (K110366) Device Description: Vitrea®CT Myocardial Ana%'sis is a post-processing softwar… | 2008 |
| * | K110366 | Syngo.CT Cardiac FunctionSummary page 1…ge Processing, Radiological (21 C.F.R. 892.2050, LLZ) Predicate Devices: GE Medical Systems CardlQ Express Version 2.0 (K073138) Siemens AG syngo.CT Cardiac Functions (K110366) Device Description: Vitrea®CT Myocardial Ana%'sis is a post-processing software option for the Vitrea® software platform, It l… | 2011 |
What descends from it? (6)
4 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 14 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 13 of the 31 ancestors have a recall of any class.
- Of its descendants, K151212 (Qi Imaging, LLC, 2015) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K073138.
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?
Vitrea® CT Myocardial Analysis is an image analysis software application for cardiac Computer Tomography (CT) studies to visualize cardiovascular anatomy and pathology and to highlight and color code the presence of hypo/hyper dense areas of myocardial tissue.
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/K112531 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112531: Vitrea CT Myocardial Analysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112531
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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