510(k) · Cleared
Recalled · Class II · 2026Spectral CT on Rails
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 May 13, 2022 as substantially equivalent to K203020 (Philips Medical Systems Nederland B.V., 2021) and 1 other predicate after a 246-day review. Its family tree reaches back 11 generations to 1993. It has been recalled 6 times.
- Decided
- May 13, 2022
- Review
- 246 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 6
- Predicates
- 2
Its longest line of descent runs back 11 generations to K930090 (1993). 20 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK930090 HelicatElscint, Inc. · 1993
- 7 generations between
- 3 generations backK163711 IQon Spectral CTPhilips Medical Systems (Cleveland), Inc. · 2017 · Recalled
- 2 generations backK193454 IQon Spectral CTPhilips Medical Systems Nederland B.V. · 2020 · Recalled
- 1 generation backK203020 Spectral CTPhilips Medical Systems Nederland B.V. · 2021 · Recalled
- This deviceK212875 Spectral CT on RailsPhilips Medical Systems Nederland B.V. · 2022
Show all 11 generations
- Root · 11 generations backK930090 HelicatElscint, Inc. · 1993
- 10 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 9 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 8 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- 7 generations backK033326 Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc. · 2003 · Recalled
- 6 generations backK060937 Brilliance VolumePhilips Medical Systems (Cleveland), Inc. · 2006 · Recalled
- 5 generations backK131773 Brilliance IctPhilips Healthcare (Cleveland) · 2013
- 4 generations backK133674 Philips Iqon Spectral CTPhilips Healthcare (Cleveland) · 2014 · Recalled
- 3 generations backK163711 IQon Spectral CTPhilips Medical Systems (Cleveland), Inc. · 2017 · Recalled
- 2 generations backK193454 IQon Spectral CTPhilips Medical Systems Nederland B.V. · 2020 · Recalled
- 1 generation backK203020 Spectral CTPhilips Medical Systems Nederland B.V. · 2021 · Recalled
- This deviceK212875 Spectral CT on RailsPhilips Medical Systems Nederland B.V. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −10 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −9 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −8 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| −7 | K033326 | Philips Plus Computed Tomography System | Philips Medical Systems, Inc. | 2003 | 131 |
| −6 | K060937 | Brilliance Volume | Philips Medical Systems (Cleveland), Inc. | 2006 | 61 |
| −5 | K131773 | Brilliance Ict | Philips Healthcare (Cleveland) | 2013 | — |
| −4 | K133674 | Philips Iqon Spectral CT | Philips Healthcare (Cleveland) | 2014 | 6 |
| −3 | K163711 | IQon Spectral CT | Philips Medical Systems (Cleveland), Inc. | 2017 | 2 |
| −2 | K193454 | IQon Spectral CT | Philips Medical Systems Nederland B.V. | 2020 | 6 |
| −1 | K203020 | Spectral CT | Philips Medical Systems Nederland B.V. | 2021 | 8 |
| 0 (this device) | K212875 | Spectral CT on Rails | Philips Medical Systems Nederland B.V. | 2022 | — |
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 |
| 2018 | 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…Spectral CT Predicate Manufacturer: Philips Medical Systems Nederland B.V. Device: 510(k) Clearance: K203020 Classification Name: Computed Tomography x-Ray System Classification Regulation:… | 2021 |
| * | K181797 | Philips CT Big Bore Sliding Gantry ConfigurationSummary page 4…iding Gantry Configuration Predicate Manufacturer: Philips Medical Systems Nederland B.V. Device: 510(k) Clearance: K181797 Classification Name: Computed Tomography x-Ray System Classification Regulation:… | 2018 |
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 |
|---|---|---|---|---|
| Mar 7, 2026 | Class II | Z-1825-2026 | Under Investigation by firm | Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2. Potential where the message of Previous Surview… |
| Jan 7, 2026 | Class II | Z-1318-2026 | 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… |
| Feb 28, 2025 | Class II | Z-1324-2025 | Under Investigation by firm | Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement. |
| Dec 13, 2023 | Class II | Z-1054-2024 | Under Investigation by firm | A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment. |
| Oct 9, 2023 | Class II | Z-0306-2024 | Under Investigation by firm | When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to be restarted. |
| Oct 9, 2023 | Class II | Z-0319-2024 | Under Investigation by firm | This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move to the desired needle position. This issue could result in… |
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 29 years and passes through 6 companies; a new generation was cleared every 2.4 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. 2022, 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 on Rails 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 Spectral CT on Rails system acquires one CT dataset — composed of data from a higher-energy detected x-ray spectrum…
Read the full statement (270 words)
The Spectral CT on Rails 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 Spectral CT on Rails 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.
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. ] 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/K212875 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212875: Spectral CT on Rails.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212875
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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