510(k) · Cleared
ClearedBrain Perfusion Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems (Cleveland), Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Feb 20, 2004 as substantially equivalent to K961464 (Elscint, Inc., 1996) and 1 other predicate after an 88-day review. Its family tree reaches back 4 generations to 1993. 3 later devices descend from it.
- Decided
- Feb 20, 2004
- Review
- 88 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K930090 (1993). 9 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK930090 HelicatElscint, Inc. · 1993
- 3 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 2 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 1 generation backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- This deviceK033677 Brain Perfusion OptionPhilips Medical Systems (Cleveland), Inc. · 2004
- Descendant · cites it directly · 1 of its ownK182716 Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V. · 2019
- Descendant · 2 generations on · 0 of its ownK201573 Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V. · 2021
- Descendant · cites it directly · 0 of its ownK133603 Philips CT Dynamic Myocardial Perfusion (DMP) ApplicationPhilips Medical Systems · 2014
Most influential descendants
Showing 3 of 3 · See all- K182716Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V. · 2019 · cites it directly1descendant
- K201573Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V. · 2021 · 2 generations on0descendants
- K133603Philips CT Dynamic Myocardial Perfusion (DMP) ApplicationPhilips Medical Systems · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −3 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −2 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −1 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| 0 (this device) | K033677 | Brain Perfusion Option | Philips Medical Systems (Cleveland), Inc. | 2004 | — |
| +1 | K182716 | Brain Perfusion (BP) application | Philips Medical Systems Nederland B.V. | 2019 | — |
| +2 | K201573 | Brain Perfusion (BP) application | Philips Medical Systems Nederland B.V. | 2021 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K961464 | Select/SPSummary page 2…lly equivalent to the legally marketed devices currently in commercial distribution, namely the Image Processing Function on the Select CT/SP in CDRH Document Control No K961464 and K012009. See Appendix "G", Equivalent Device Comparison Matrix. This opinion is based on the fact that comparing the Image Pr… | 1996 |
| * | K012009 | MX8000 Idt CT SystemSummary page 2…nt to the legally marketed devices currently in commercial distribution, namely the Image Processing Function on the Select CT/SP in CDRH Document Control No K961464 and K012009. See Appendix "G", Equivalent Device Comparison Matrix. This opinion is based on the fact that comparing the Image Processing Fun… | 2001 |
| * | — | Mx8000IDT Named without a submission number |
What descends from it? (3)
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 11 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K182716 (Philips Medical Systems Nederland B.V., 2019) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K961464.
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.
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 Philips Medical Systems CT Brain Perfusion Option is intended to assist the user by providing a diagnostic patient imaging tool to be included on a CT workspace. It is intended to assist the user-selected area of interest to generate qualitative and quantitative information about changes in image intensity over time. It supports the analysis of dynamic/serial CT after injection of contrast, by calculating the parameters related to brain perfusion and…
Read the full statement (153 words)
The Philips Medical Systems CT Brain Perfusion Option is intended to assist the user by providing a diagnostic patient imaging tool to be included on a CT workspace. It is intended to assist the user-selected area of interest to generate qualitative and quantitative information about changes in image intensity over time. It supports the analysis of dynamic/serial CT after injection of contrast, by calculating the parameters related to brain perfusion and displays the results as a composite (single image that is calculated from a set of time course images at a single location) images. This software runs on the Philips Medical Systems Brilliance TM Workspace of a CT System.
The Brain Perfusion Option is used in a Philips Medical Systems Brilliance TM Workspace of a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033677 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033677: Brain Perfusion Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033677
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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