510(k) · Cleared
Recalled · Class II · 2014Myoperfusion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshibamedical Systems Corporation · JAK System, X-Ray, Tomography, Computed
Cleared on Dec 12, 2013 as substantially equivalent to K112531 (Vital Images, Inc., 2011) and 2 other predicates after a 122-day review. Its family tree reaches back 9 generations to 1997. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 12, 2013
- Review
- 122 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 9 generations to K971684 (1997). 32 ancestors in all, the oldest K913770 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 5 generations between
- 3 generations backK092519 Syngo.XSiemens AG Medical Solutions · 2009 · Recalled
- 2 generations backK110366 Syngo.CT Cardiac FunctionSiemens AG · 2011 · Recalled
- 1 generation backK112531 Vitrea CT Myocardial AnalysisVital Images, Inc. · 2011
- This deviceK132523 MyoperfusionToshibamedical Systems Corporation · 2013
- Descendant · cites it directly · 0 of its ownK150104 Vitrea CT Myocardial PerfusionVital Images, Inc. · 2015
Show all 9 generations
- Root · 9 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 8 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 7 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 6 generations backK052423 Magnetom Systems with Syngo Expert - I OptionSiemens Medi Cal Solutions, Inc. · 2006
- 5 generations backK061964 Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2006
- 4 generations backK072728 Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2008
- 3 generations backK092519 Syngo.XSiemens AG Medical Solutions · 2009 · Recalled
- 2 generations backK110366 Syngo.CT Cardiac FunctionSiemens AG · 2011 · Recalled
- 1 generation backK112531 Vitrea CT Myocardial AnalysisVital Images, Inc. · 2011
- This deviceK132523 MyoperfusionToshibamedical Systems Corporation · 2013
Most influential descendants
Showing 1 of 1 · See all- K150104Vitrea CT Myocardial PerfusionVital Images, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −8 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −7 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −6 | K052423 | Magnetom Systems with Syngo Expert - I Option | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −5 | K061964 | Syngo Multimodality Workplace | Siemens AG Medical Solutions | 2006 | — |
| −4 | K072728 | Syngo Multimodality Workplace | Siemens AG Medical Solutions | 2008 | — |
| −3 | K092519 | Syngo.X | Siemens AG Medical Solutions | 2009 | 4 |
| −2 | K110366 | Syngo.CT Cardiac Function | Siemens AG | 2011 | 1 |
| −1 | K112531 | Vitrea CT Myocardial Analysis | Vital Images, Inc. | 2011 | — |
| 0 (this device) | K132523 | Myoperfusion | Toshibamedical Systems Corporation | 2013 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 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? (3)
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 |
|---|---|---|---|
| * | K112531 | Vitrea CT Myocardial AnalysisSummary page 2…edical Systems Siemens Medical Solutions, Inc. 510(k) Clearance K1 12531 K073138 K1 10366 Number… | 2011 |
| * | K073138 | Cardiq Express Version 2.0Summary page 2…edical Solutions, Inc. 510(k) Clearance K1 12531 K073138 K1 10366 Number _________ Clea… | 2008 |
| * | K110366 | Syngo.CT Cardiac FunctionSummary page 2…Solutions, Inc. 510(k) Clearance K1 12531 K073138 K1 10366 Number _________ Clearance Date… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150104 | Vitrea CT Myocardial Perfusion | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 13, 2014 | Class II | Z-2085-2014 | Software design | Partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data Module) to the CARESCAPE B850, B650 or B450 monitor with software version 2 the PDM may not start communicating to the monitor… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 13 of the 32 ancestors have a recall of any class.
- Of its descendants, K150104 (Vital Images, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K112531.
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. 2013, 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?
This software is intended to be used for the visualization of non-reversible perfusion defects (hypo/hyper dense areas) in patients with angina or with a previous myocardial infarct. Included software tools may aid a trained user in monitoring the disease state and treatment over time. This software provides maps and the values used to generate the maps. 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/K132523 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132523: Myoperfusion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132523
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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