510(k) · Cleared
Recalled · Class II · 2016Philips Spectral CT Applications
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Nethrlands BV · JAK System, X-Ray, Tomography, Computed
Cleared on Aug 7, 2015 as substantially equivalent to K133674 (Philips Healthcare (Cleveland), 2014) after a 144-day review. Its family tree reaches back 8 generations to 1993. 1 later device descends from it. It has been recalled once.
- Decided
- Aug 7, 2015
- Review
- 144 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 8 generations to K930090 (1993). 13 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK930090 HelicatElscint, Inc. · 1993
- 7 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 6 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 5 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- 4 generations backK033326 Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc. · 2003 · Recalled
- 3 generations backK060937 Brilliance VolumePhilips Medical Systems (Cleveland), Inc. · 2006 · Recalled
- 2 generations backK131773 Brilliance IctPhilips Healthcare (Cleveland) · 2013
- 1 generation backK133674 Philips Iqon Spectral CTPhilips Healthcare (Cleveland) · 2014 · Recalled
- This deviceK150665 Philips Spectral CT ApplicationsPhilips Medical Systems Nethrlands BV · 2015
- Descendant · cites it directly · 0 of its ownK260169 AV Cardiac CTPhilips Medical Systems Nederland B.V. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260169AV Cardiac CTPhilips Medical Systems Nederland B.V. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −7 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −6 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −5 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| −4 | K033326 | Philips Plus Computed Tomography System | Philips Medical Systems, Inc. | 2003 | 131 |
| −3 | K060937 | Brilliance Volume | Philips Medical Systems (Cleveland), Inc. | 2006 | 61 |
| −2 | K131773 | Brilliance Ict | Philips Healthcare (Cleveland) | 2013 | — |
| −1 | K133674 | Philips Iqon Spectral CT | Philips Healthcare (Cleveland) | 2014 | 6 |
| 0 (this device) | K150665 | Philips Spectral CT Applications | Philips Medical Systems Nethrlands BV | 2015 | — |
| +1 | K260169 | AV Cardiac CT | Philips Medical Systems Nederland B.V. | 2026 | — |
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 |
|---|---|---|
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | K133674 | Philips Iqon Spectral CTSummary page 4…n: 21 CFR 892.1750 Class: II Product Code: JAK, LLZ Panel: Radiology Predicate devices IQon Spectral CT (K133674) EBW NM 2.0 (K111336) Brilliance iCT (K060937) Premarket Notification [510(… | 2014 |
| † | K060937 | Brilliance Volume | 2006 |
| † | K111336 | EBW NM 2.0 | 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 |
|---|---|---|---|
| K260169 | AV Cardiac CT | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 14, 2016 | Class II | Z-0706-2017 | Software design | A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Applications while filming, saving and annotating images |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
- 6 of the 13 ancestors have a recall of any class.
- Of its descendants, K260169 (Philips Medical Systems Nederland B.V., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K133674.
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?
The Philips Spectral CT Applications support viewing and analysis of images at energies selected from the available spectrum in order to provide information about the chemical composition of the body materials and/or contrast agents. The Spectral CT Applications provide for the quantification and graphical display of attenuation, material density, and effective atomic number. This information may be used by a trained healthcare professional as a…
Read the full statement (145 words)
The Philips Spectral CT Applications support viewing and analysis of images at energies selected from the available spectrum in order to provide information about the chemical composition of the body materials and/or contrast agents. The Spectral CT Applications provide for the quantification and graphical display of attenuation, material density, and effective atomic number. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures.
The Spectral enhanced Advanced Vessel Analysis (sAVA) application is intended to assist clinicians in viewing and evaluating CT images, for the inspection of contrast-enhanced vessels.
The Spectral enhanced Comprehensive Cardiac Analysis (sCCA) application is intended to assist clinicians in viewing and evaluating cardiovascular CT images.
The Spectral enhanced Tumor Tracking (sTT) application is intended to assist clinicians in viewing and evaluating CT images, for the inspection of tumors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150665 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150665: Philips Spectral CT Applications.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150665
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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