510(k) · Cleared
ClearedPhilips CT Dynamic Myocardial Perfusion (DMP) Application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems · JAK System, X-Ray, Tomography, Computed
Cleared on Sep 25, 2014 as substantially equivalent to K033677 (Philips Medical Systems (Cleveland), Inc., 2004) and 2 other predicates after a 304-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Sep 25, 2014
- Review
- 304 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K930090 (1993). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK930090 HelicatElscint, Inc. · 1993
- 5 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 4 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 3 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- 2 generations backK033326 Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc. · 2003 · Recalled
- 1 generation backK060937 Brilliance VolumePhilips Medical Systems (Cleveland), Inc. · 2006 · Recalled
- This deviceK133603 Philips CT Dynamic Myocardial Perfusion (DMP) ApplicationPhilips Medical Systems · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −5 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −4 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −3 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| −2 | K033326 | Philips Plus Computed Tomography System | Philips Medical Systems, Inc. | 2003 | 131 |
| −1 | K060937 | Brilliance Volume | Philips Medical Systems (Cleveland), Inc. | 2006 | 61 |
| 0 (this device) | K133603 | Philips CT Dynamic Myocardial Perfusion (DMP) Application | Philips Medical Systems | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K033677 | Brain Perfusion OptionSummary page 5…ution, namely: 1. Predicate Device: Philips Brain Perfusion Manufacturer: Philips Medical Systems (Cleveland), Inc. Predicate Device k#: K033677 2. Predicate Device: CardioCT Manufacturer: Shina Predicate Device k#: K070226 3. Predi… | 2004 |
| * | K070226 | CardioctSummary page 5…ystems (Cleveland), Inc. Predicate Device k#: K033677 2. Predicate Device: CardioCT Manufacturer: Shina Predicate Device k#: K070226 3. Predicate Device: Philips Brilliance Volume Manufacturer: Philips Medical Systems (Cleveland), Inc.… | 2007 |
| * | K060937 | Brilliance VolumeSummary page 5…k#: K070226 3. Predicate Device: Philips Brilliance Volume Manufacturer: Philips Medical Systems (Cleveland), Inc. Predicate Device k#: K060937 4. Device Description: Summary of functions of the device and its major components The CT Dynamic Myocard… | 2006 |
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 21 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 5 of the 13 ancestors have a recall of any class.
- 1 other device also cites its predicate K033677.
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. 2014, 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?
The CT Dynamic Myocardial Perfusion (CT DMP) application is intended to assist clinicians in the visualization and
diagnostic assessment of cardiac images focusing on the left ventricular myocardium: specifically providing qualitative
myocardial blood flow measurements for CT images. The application supports axial, ECG gated CT images, consisting
of multiple time shots within the same study of the same myocardial region overtime (i.e., dynamic CT scans), after the
injection of intravenous contrast. The application displays the results as a composite (single image that is calculated from
a set of time course images at a single location) image.
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/K133603 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133603: Philips CT Dynamic Myocardial Perfusion (DMP) Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133603
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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