510(k) · Cleared
Recalled · Class II · 2025Spectral CT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Nederland B.V. · JAK System, X-Ray, Tomography, Computed
Cleared on Feb 26, 2021 as substantially equivalent to K193454 (Philips Medical Systems Nederland B.V., 2020) after a 147-day review. Its family tree reaches back 10 generations to 1993. 5 later devices descend from it. It has been recalled 8 times.
- Decided
- Feb 26, 2021
- Review
- 147 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 8
- Predicates
- 1
Its longest line of descent runs back 10 generations to K930090 (1993). 15 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK930090 HelicatElscint, Inc. · 1993
- 6 generations between
- 3 generations backK133674 Philips Iqon Spectral CTPhilips Healthcare (Cleveland) · 2014 · Recalled
- 2 generations backK163711 IQon Spectral CTPhilips Medical Systems (Cleveland), Inc. · 2017 · Recalled
- 1 generation backK193454 IQon Spectral CTPhilips Medical Systems Nederland B.V. · 2020 · Recalled
- This deviceK203020 Spectral CTPhilips Medical Systems Nederland B.V. · 2021
- Descendant · cites it directly · 3 of its ownK240844 Spectral CT 7500 RTPhilips Medical Systems Technologies, Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK253649 Spectral CT Verida FamilyPhilips Medical Systems Technologies, Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK252992 CT Rembra RT; CT Areta RT; CT RembraPhilips Healthcare (Suzhou) Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK244008 Spectral CTPhilips Medical Systems Technologies, Ltd. · 2025 · Recalled
- Descendant · cites it directly · 0 of its ownK212875 Spectral CT on RailsPhilips Medical Systems Nederland B.V. · 2022 · Recalled
Show all 10 generations
- Root · 10 generations backK930090 HelicatElscint, Inc. · 1993
- 9 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 8 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 7 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- 6 generations backK033326 Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc. · 2003 · Recalled
- 5 generations backK060937 Brilliance VolumePhilips Medical Systems (Cleveland), Inc. · 2006 · Recalled
- 4 generations backK131773 Brilliance IctPhilips Healthcare (Cleveland) · 2013
- 3 generations backK133674 Philips Iqon Spectral CTPhilips Healthcare (Cleveland) · 2014 · Recalled
- 2 generations backK163711 IQon Spectral CTPhilips Medical Systems (Cleveland), Inc. · 2017 · Recalled
- 1 generation backK193454 IQon Spectral CTPhilips Medical Systems Nederland B.V. · 2020 · Recalled
- This deviceK203020 Spectral CTPhilips Medical Systems Nederland B.V. · 2021
Most influential descendants
Showing 5 of 5 · See all- K240844Spectral CT 7500 RTPhilips Medical Systems Technologies, Ltd. · 2024 · cites it directly3descendants
- K253649Spectral CT Verida FamilyPhilips Medical Systems Technologies, Ltd. · 2026 · 2 generations on0descendants
- K252992CT Rembra RT; CT Areta RT; CT RembraPhilips Healthcare (Suzhou) Co., Ltd. · 2026 · 2 generations on0descendants
- K244008Spectral CTPhilips Medical Systems Technologies, Ltd. · 2025 · cites it directly0descendants
- K212875Spectral CT on RailsPhilips Medical Systems Nederland B.V. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −9 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −8 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −7 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| −6 | K033326 | Philips Plus Computed Tomography System | Philips Medical Systems, Inc. | 2003 | 131 |
| −5 | K060937 | Brilliance Volume | Philips Medical Systems (Cleveland), Inc. | 2006 | 61 |
| −4 | K131773 | Brilliance Ict | Philips Healthcare (Cleveland) | 2013 | — |
| −3 | K133674 | Philips Iqon Spectral CT | Philips Healthcare (Cleveland) | 2014 | 6 |
| −2 | K163711 | IQon Spectral CT | Philips Medical Systems (Cleveland), Inc. | 2017 | 2 |
| −1 | K193454 | IQon Spectral CT | Philips Medical Systems Nederland B.V. | 2020 | 6 |
| 0 (this device) | K203020 | Spectral CT | Philips Medical Systems Nederland B.V. | 2021 | — |
| +1 | K240844 | Spectral CT 7500 RT | Philips Medical Systems Technologies, Ltd. | 2024 | — |
| +2 | K253649 | Spectral CT Verida Family | Philips Medical Systems Technologies, Ltd. | 2026 | — |
| +2 | K252992 | CT Rembra RT; CT Areta RT; CT Rembra | Philips Healthcare (Suzhou) Co., Ltd. | 2026 | — |
| +1 | K244008 | Spectral CT | Philips Medical Systems Technologies, Ltd. | 2025 | 3 |
| +1 | K212875 | Spectral CT on Rails | Philips Medical Systems Nederland B.V. | 2022 | 6 |
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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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.
What descends from it? (5)
3 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 |
|---|---|---|---|---|
| May 29, 2025 | Class II | Z-2034-2025 | Under Investigation by firm | Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT performance. |
| Nov 16, 2024 | Class II | Z-0583-2025 | Under Investigation by firm | Potential for a plan box not updated issue during Interventional procedure with Spectral CT that may lead to a collision with the operator or with the needle placed inside the patient, and an incorrect patient ID software issue that may… |
| Mar 29, 2024 | Class II | Z-1756-2024 | Under Investigation by firm | Potential for third party oncology marking laser to be reflected off the gantry cover surface, which can potentially lead to misdiagnosis and subsequent incorrect treatment. |
| Dec 13, 2023 | Class II | Z-1055-2024 | Under Investigation by firm | A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment. |
| Nov 30, 2023 | Class II | Z-0725-2024 | Software design | Multiple software issues that affect device functionality. |
| Mar 17, 2023 | Class II | Z-1584-2023 | Under Investigation by firm | Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operators foot. If foot or leg entrapment occurs while pressing Unload Pedal, the risk to operators may include: pain, muscle or… |
| Jun 8, 2021 | Class II | Z-2318-2021 | Software design | When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient. |
| May 1, 2021 | Class II | Z-1986-2021 | Device Design | Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining… |
The 5 latest of 8 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 28 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
- 8 of the 15 ancestors have a recall of any class.
- Of its descendants, K240844 (Philips Medical Systems Technologies, Ltd., 2024) has gone furthest, with 3 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. 2021, 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 Spectral CT is a Computed Tomography X-Ray System intended to produce 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 Spectral CT system acquires one CT dataset — composed of data from a higher-energy detected x-ray spectrum and a…
Read the full statement (277 words)
The Spectral CT is a Computed Tomography X-Ray System intended to produce 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 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 in patients of all ages, and to be used for diagnostic imaging in radiology, interventional radiology, and cardiology and in oncology as part of treatment preparation and radiation therapy planning.
The system is also intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*.
The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society.
*Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
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/K203020 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203020: Spectral CT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203020
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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