510(k) · Cleared
ClearedVitrea CT Myocardial Perfusion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vital Images, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Apr 17, 2015 as substantially equivalent to K132523 (Toshibamedical Systems Corporation, 2013) and 1 other predicate after an 87-day review. Its family tree reaches back 10 generations to 1997.
- Decided
- Apr 17, 2015
- Review
- 87 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K971684 (1997). 33 ancestors in all, the oldest K913770 (1991). No later device cites it as a predicate yet.
- Root · 10 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 6 generations between
- 3 generations backK110366 Syngo.CT Cardiac FunctionSiemens AG · 2011 · Recalled
- 2 generations backK112531 Vitrea CT Myocardial AnalysisVital Images, Inc. · 2011
- 1 generation backK132523 MyoperfusionToshibamedical Systems Corporation · 2013 · Recalled
- This deviceK150104 Vitrea CT Myocardial PerfusionVital Images, Inc. · 2015
Show all 10 generations
- Root · 10 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 9 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 8 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 7 generations backK052423 Magnetom Systems with Syngo Expert - I OptionSiemens Medi Cal Solutions, Inc. · 2006
- 6 generations backK061964 Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2006
- 5 generations backK072728 Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2008
- 4 generations backK092519 Syngo.XSiemens AG Medical Solutions · 2009 · Recalled
- 3 generations backK110366 Syngo.CT Cardiac FunctionSiemens AG · 2011 · Recalled
- 2 generations backK112531 Vitrea CT Myocardial AnalysisVital Images, Inc. · 2011
- 1 generation backK132523 MyoperfusionToshibamedical Systems Corporation · 2013 · Recalled
- This deviceK150104 Vitrea CT Myocardial PerfusionVital Images, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −9 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −8 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −7 | K052423 | Magnetom Systems with Syngo Expert - I Option | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −6 | K061964 | Syngo Multimodality Workplace | Siemens AG Medical Solutions | 2006 | — |
| −5 | K072728 | Syngo Multimodality Workplace | Siemens AG Medical Solutions | 2008 | — |
| −4 | K092519 | Syngo.X | Siemens AG Medical Solutions | 2009 | 4 |
| −3 | K110366 | Syngo.CT Cardiac Function | Siemens AG | 2011 | 1 |
| −2 | K112531 | Vitrea CT Myocardial Analysis | Vital Images, Inc. | 2011 | — |
| −1 | K132523 | Myoperfusion | Toshibamedical Systems Corporation | 2013 | 1 |
| 0 (this device) | K150104 | Vitrea CT Myocardial Perfusion | Vital Images, Inc. | 2015 | — |
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 |
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 JAK? 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 JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 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 |
|---|---|---|---|
| * | K132523 | MyoperfusionSummary page 5…number MyoPerfusion, CSMP-001A Primary Toshiba Medical K132523 Predicate Systems Corporation Device CT Myocardia… | 2013 |
| * | K112531 | Vitrea CT Myocardial AnalysisSummary page 5…Predicate Systems Corporation Device CT Myocardial Analysis Secondary Vital Images, Inc. K112531 Predicate Device Device Description: Vitrea CT Myocardial P… | 2011 |
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 18 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 14 of the 33 ancestors have a recall of any class.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
Vitrea® CT Myocardial Perfusion is intended to assist a trained user for the visualization of hypo/hyper dense areas in patients with angina or with a previous myocardial infarction to assess the disease state and treatment. This software provides semi-automated heart and left ventricle segmentation and color polar maps of the myocardial tissue.
The information provided is intended to be qualitative in nature and, when used by a qualified physician, may aid in the identification of myocardial enhancement defects and the follow up of such findings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150104 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150104: Vitrea CT Myocardial Perfusion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150104
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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