510(k) · Cleared
Recalled · Class II · 2026Spectral CT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Technologies, Ltd. · JAK System, X-Ray, Tomography, Computed
Cleared on May 16, 2025 as substantially equivalent to K203020 (Philips Medical Systems Nederland B.V., 2021) and 1 other predicate after a 141-day review. Its family tree reaches back 12 generations to 1993. It has been recalled 3 times.
- Decided
- May 16, 2025
- Review
- 141 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 12 generations to K930090 (1993). 20 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK930090 HelicatElscint, Inc. · 1993
- 8 generations between
- 3 generations backK193454 IQon Spectral CTPhilips Medical Systems Nederland B.V. · 2020 · Recalled
- 2 generations backK203020 Spectral CTPhilips Medical Systems Nederland B.V. · 2021 · Recalled
- 1 generation backK240844 Spectral CT 7500 RTPhilips Medical Systems Technologies, Ltd. · 2024
- This deviceK244008 Spectral CTPhilips Medical Systems Technologies, Ltd. · 2025
Show all 12 generations
- Root · 12 generations backK930090 HelicatElscint, Inc. · 1993
- 11 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 10 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 9 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- 8 generations backK033326 Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc. · 2003 · Recalled
- 7 generations backK060937 Brilliance VolumePhilips Medical Systems (Cleveland), Inc. · 2006 · Recalled
- 6 generations backK131773 Brilliance IctPhilips Healthcare (Cleveland) · 2013
- 5 generations backK133674 Philips Iqon Spectral CTPhilips Healthcare (Cleveland) · 2014 · Recalled
- 4 generations backK163711 IQon Spectral CTPhilips Medical Systems (Cleveland), Inc. · 2017 · Recalled
- 3 generations backK193454 IQon Spectral CTPhilips Medical Systems Nederland B.V. · 2020 · Recalled
- 2 generations backK203020 Spectral CTPhilips Medical Systems Nederland B.V. · 2021 · Recalled
- 1 generation backK240844 Spectral CT 7500 RTPhilips Medical Systems Technologies, Ltd. · 2024
- This deviceK244008 Spectral CTPhilips Medical Systems Technologies, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −11 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −10 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −9 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| −8 | K033326 | Philips Plus Computed Tomography System | Philips Medical Systems, Inc. | 2003 | 131 |
| −7 | K060937 | Brilliance Volume | Philips Medical Systems (Cleveland), Inc. | 2006 | 61 |
| −6 | K131773 | Brilliance Ict | Philips Healthcare (Cleveland) | 2013 | — |
| −5 | K133674 | Philips Iqon Spectral CT | Philips Healthcare (Cleveland) | 2014 | 6 |
| −4 | K163711 | IQon Spectral CT | Philips Medical Systems (Cleveland), Inc. | 2017 | 2 |
| −3 | K193454 | IQon Spectral CT | Philips Medical Systems Nederland B.V. | 2020 | 6 |
| −2 | K203020 | Spectral CT | Philips Medical Systems Nederland B.V. | 2021 | 8 |
| −1 | K240844 | Spectral CT 7500 RT | Philips Medical Systems Technologies, Ltd. | 2024 | — |
| 0 (this device) | K244008 | Spectral CT | Philips Medical Systems Technologies, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2017 | 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? (2)
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 |
|---|---|---|---|
| * | K203020 | Spectral CTSummary page 4…nformation provided above, the proposed Spectral CT system is considered substantially equivalent to the currently marketed primary predicate device, Spectral CT system (K203020), in terms of Indications for Use. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 C… | 2021 |
| * | K240844 | Spectral CT 7500 RTSummary page 5…ice: Manufacturer: Philips Medical Systems Nederland B.V. 510(k) Clearance: K240844 Classification Name: Computed Tomography X-ray System Classi… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 21, 2026 | Class II | Z-0078-2027 | Under Investigation by firm | Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system motion. |
| Aug 18, 2026 | Class II | Z-3155-2026 | Radiation Control for Health and Safety Act | The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in the patient receiving additional radiation. |
| Jan 7, 2026 | Class II | Z-1317-2026 | Process change control | As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 7 companies; a new generation was cleared every 2.6 years on median.
- 12 of the 20 ancestors have a recall of any class.
- 2 other devices also cite its predicate K203020.
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. 2025, 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 system 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 support, 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 (317 words)
The Spectral CT system 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 support, 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 Extended field of view images and respiratory correlated scanning (4DCT) are for treatment preparation and radiation therapy planning/simulation usage only.
This device is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.
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 as stated in the FDA summary.
https://510kreport.com/device/K244008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K244008: 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/K244008
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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