510(k) · Cleared
Recalled · Class II · 2018Philips Iqon Spectral CT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Healthcare (Cleveland) · JAK System, X-Ray, Tomography, Computed
Cleared on Nov 21, 2014 as substantially equivalent to K131773 (Philips Healthcare (Cleveland), 2013) after a 357-day review. Its family tree reaches back 7 generations to 1993. 10 later devices descend from it. It has been recalled 6 times.
- Decided
- Nov 21, 2014
- Review
- 357 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 7 generations to K930090 (1993). 12 ancestors in all. 10 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK930090 HelicatElscint, Inc. · 1993
- 6 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 5 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 4 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- 3 generations backK033326 Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc. · 2003 · Recalled
- 2 generations backK060937 Brilliance VolumePhilips Medical Systems (Cleveland), Inc. · 2006 · Recalled
- 1 generation backK131773 Brilliance IctPhilips Healthcare (Cleveland) · 2013
- This deviceK133674 Philips Iqon Spectral CTPhilips Healthcare (Cleveland) · 2014
- Descendant · cites it directly · 7 of its ownK163711 IQon Spectral CTPhilips Medical Systems (Cleveland), Inc. · 2017 · Recalled
- Descendant · 2 generations on · 6 of its ownK193454 IQon Spectral CTPhilips Medical Systems Nederland B.V. · 2020 · Recalled
- Descendant · 3 generations on · 5 of its ownK203020 Spectral CTPhilips Medical Systems Nederland B.V. · 2021 · Recalled
- Descendant · 4 generations on · 3 of its ownK240844 Spectral CT 7500 RTPhilips Medical Systems Technologies, Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK150665 Philips Spectral CT ApplicationsPhilips Medical Systems Nethrlands BV · 2015 · Recalled
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K163711IQon Spectral CTPhilips Medical Systems (Cleveland), Inc. · 2017 · cites it directly7descendants
- K193454IQon Spectral CTPhilips Medical Systems Nederland B.V. · 2020 · 2 generations on6descendants
- K203020Spectral CTPhilips Medical Systems Nederland B.V. · 2021 · 3 generations on5descendants
- K240844Spectral CT 7500 RTPhilips Medical Systems Technologies, Ltd. · 2024 · 4 generations on3descendants
- K150665Philips Spectral CT ApplicationsPhilips Medical Systems Nethrlands BV · 2015 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −6 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −5 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −4 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| −3 | K033326 | Philips Plus Computed Tomography System | Philips Medical Systems, Inc. | 2003 | 131 |
| −2 | K060937 | Brilliance Volume | Philips Medical Systems (Cleveland), Inc. | 2006 | 61 |
| −1 | K131773 | Brilliance Ict | Philips Healthcare (Cleveland) | 2013 | — |
| 0 (this device) | K133674 | Philips Iqon Spectral CT | Philips Healthcare (Cleveland) | 2014 | — |
| +1 | K163711 | IQon Spectral CT | Philips Medical Systems (Cleveland), Inc. | 2017 | 2 |
| +2 | K193454 | IQon Spectral CT | Philips Medical Systems Nederland B.V. | 2020 | 6 |
| +3 | K203020 | Spectral CT | Philips Medical Systems Nederland B.V. | 2021 | 8 |
| +4 | K240844 | Spectral CT 7500 RT | Philips Medical Systems Technologies, Ltd. | 2024 | — |
| +1 | K150665 | Philips Spectral CT Applications | Philips Medical Systems Nethrlands BV | 2015 | 1 |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K131773 | Brilliance IctSummary page 4…750 Class: II Product Code: JAK Panel: Radiology Predicate devices Philips Brilliance iCT (K131773) Premarket Notification [510(k)] Submission Philips Medical Systems (Cleveland), Inc. Sectio… | 2013 |
What descends from it? (10)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 8, 2018 | Class II | Z-1414-2018 | Software design | Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities. |
| Jan 11, 2018 | Class II | Z-0841-2018 | Under Investigation by firm | 23 Software related issues for the IQon Spectral CT with 4.7.2 software version. These issues include: " Software errors that may result in CT spectral images misrepresentation or incorrect treatment; " Software errors that may result in… |
| Nov 8, 2017 | Class II | Z-0333-2018 | Device Design | There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the… |
| Dec 16, 2016 | Class II | Z-1006-2017 | Software design | Multiple issues have caused the device to result in CT rescans or incorrect scan location or misrepresentation of image results. |
| Nov 14, 2016 | Class II | Z-0705-2017 | Software design | A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Applications while filming, saving and annotating images |
| Oct 13, 2016 | Class III | Z-0598-2017 | Labeling Change Control | The product label does not include the correct current rating. |
The 5 latest of 6 recalls; the web page lists all.
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 2.6 years on median.
- 5 of the 12 ancestors have a recall of any class.
- Of its descendants, K163711 (Philips Medical Systems (Cleveland), Inc., 2017) has gone furthest, with 7 descendants of its own.
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 Philips IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. The IQon Spectral CT system acquires one CT dataset – composed of data from a higher-energy detected x-ray spectrum…
Read the full statement (167 words)
The Philips IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
The IQon Spectral CT system acquires one CT dataset – composed of data from a higher-energy detected x-ray spectrum and a lower- energy detected x-ray spectrum. The two spectra may be used to analyze the differences in the energy dependence of the attenuation coefficient of different materials. This allows for the generation of images at energies selected from the available spectrum and to provide information about the chemical composition of the body materials and/or contrast agents. Additionally, materials analysis provides 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133674 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133674: Philips Iqon Spectral CT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133674
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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