510(k) · Cleared
Recalled · Class II · 2026Philips Plus Computed Tomography System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Oct 29, 2003 as substantially equivalent to K012009 (Marconi Medical Systems, Inc., 2001) and 1 other predicate after a 13-day review. Its family tree reaches back 4 generations to 1993. 214 later devices descend from it. It has been recalled 131 times.
- Decided
- Oct 29, 2003
- Review
- 13 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 131
- Predicates
- 2
Its longest line of descent runs back 4 generations to K930090 (1993). 9 ancestors in all. 214 later devices descend from it, 9 citing it directly.
- Root · 4 generations backK930090 HelicatElscint, Inc. · 1993
- 3 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 2 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 1 generation backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- This deviceK033326 Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc. · 2003
- Descendant · cites it directly · 147 of its ownK042293 Brilliance CT, Private Practice CV Configuration, CT ScannerPhilips Medical Systems (Cleveland), Inc. · 2004 · Recalled
- Descendant · 2 generations on · 92 of its ownK130159 Qlab Quantification Software Heart ModelPhilips Health Care · 2013
- Descendant · 3 generations on · 91 of its ownK132165 Qlab Quantification SoftwarePhilips Ultrasound, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 49 of its ownK062650 EP Navigator SoftwarePhilips Medical Systems · 2006
- Descendant · 4 generations on · 45 of its ownK171314 QLAB Advanced Quantification SoftwarePhilips Health Care · 2017
Showing 5 of 214 descendants. See all descendants
Descendants cleared per year
2004high 32 (2025) · low 1 (2004)2026
Most influential descendants
Showing 5 of 214 · See all- K042293Brilliance CT, Private Practice CV Configuration, CT ScannerPhilips Medical Systems (Cleveland), Inc. · 2004 · cites it directly147descendants
- K130159Qlab Quantification Software Heart ModelPhilips Health Care · 2013 · 2 generations on92descendants
- K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc. · 2013 · 3 generations on91descendants
- K062650EP Navigator SoftwarePhilips Medical Systems · 2006 · 2 generations on49descendants
- K171314QLAB Advanced Quantification SoftwarePhilips Health Care · 2017 · 4 generations on45descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −3 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −2 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −1 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| 0 (this device) | K033326 | Philips Plus Computed Tomography System | Philips Medical Systems, Inc. | 2003 | — |
| +1 | K042293 | Brilliance CT, Private Practice CV Configuration, CT Scanner | Philips Medical Systems (Cleveland), Inc. | 2004 | 1 |
| +2 | K130159 | Qlab Quantification Software Heart Model | Philips Health Care | 2013 | — |
| +3 | K132165 | Qlab Quantification Software | Philips Ultrasound, Inc. | 2013 | 1 |
| +2 | K062650 | EP Navigator Software | Philips Medical Systems | 2006 | — |
| +4 | K171314 | QLAB Advanced Quantification Software | Philips Health Care | 2017 | — |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 6 | 0 |
| 2014 | 7 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 10 | 0 |
| 2018 | 12 | 0 |
| 2019 | 7 | 0 |
| 2020 | 20 | 0 |
| 2021 | 14 | 0 |
| 2022 | 21 | 0 |
| 2023 | 17 | 0 |
| 2024 | 17 | 0 |
| 2025 | 32 | 0 |
| 2026 | 25 | 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.
What descends from it? (214)
See all 2149 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042293 | Brilliance CT, Private Practice CV Configuration, CT Scanner | 2004 | 147 |
| K060937 | Brilliance Volume | 2006 | 24 |
| K051170 | Gemini GXL | 2005 | 13 |
| K172135 | uCT Computed Tomography X-ray System | 2018 | 12 |
| K160743 | Philips Ingenuity CT | 2016 | 9 |
| K151383 | NeuViz 128 Multi-slice CT Scanner System | 2015 | 2 |
| K153444 | Philips Multislice CT System with Low Dose CT Lung Cancer | 2016 | 1 |
| K071308 | Modification to Neuviz Dual Multi-Slice CT Scanner System | 2007 | 1 |
| K051351 | Precedence Spect/CT Imaging System | 2005 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 7, 2026 | Class II | Z-3043-2026 | Radiation Control for Health and Safety Act | Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment. |
| Aug 13, 2025 | Class II | Z-2595-2025 | Process control | The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. |
| Aug 13, 2025 | Class II | Z-2604-2025 | Process control | The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. |
| Aug 13, 2025 | Class II | Z-2602-2025 | Process control | The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. |
| Aug 13, 2025 | Class II | Z-2603-2025 | Process control | The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. |
| May 1, 2021 | Class II | Z-1982-2021 | 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… |
| Oct 18, 2018 | Class II | Z-0543-2019 | Process control | There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall |
| Oct 18, 2018 | Class II | Z-0544-2019 | Process control | There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall |
| Jul 3, 2018 | Class II | Z-1143-2019 | Device Design | Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. The firm has identified systems that may be at risk for this failure due to the collimator compensator… |
| Mar 30, 2018 | Class II | Z-2174-2018 | Device Design | The patient support head holder could contact the back ISO shelter wall during manual or motorized motion through the gantry bore. This may result in a serious injury that would require medical intervention to preclude permanent… |
| Feb 21, 2018 | Class II | Z-1396-2018 | Under Investigation by firm | Surview scan with tube current lower than 30 mA is unable to be initialized. |
| Feb 8, 2018 | Class II | Z-1406-2018 | Software design | Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities. |
| Feb 8, 2018 | Class II | Z-1413-2018 | Software design | Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities. |
| Feb 8, 2018 | Class II | Z-1407-2018 | Software design | Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities. |
| Feb 8, 2018 | Class II | Z-1405-2018 | Software design | Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities. |
| Feb 8, 2018 | Class II | Z-1404-2018 | Software design | Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities. |
| Nov 10, 2017 | Class II | Z-0389-2018 | Under Investigation by firm | Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the… |
| Nov 12, 2016 | Class II | Z-0694-2017 | Software design | Software error due to the filament on timer |
| Nov 12, 2016 | Class II | Z-0693-2017 | Software design | Software error due to the filament on timer |
| Aug 24, 2016 | Class II | Z-0012-2017 | Software design | The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstructed images may exhibit degraded image… |
| Aug 24, 2016 | Class II | Z-0009-2017 | Software design | The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstructed images may exhibit degraded image… |
| Aug 24, 2016 | Class II | Z-0010-2017 | Software design | The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstructed images may exhibit degraded image… |
| Aug 24, 2016 | Class II | Z-0011-2017 | Software design | The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstructed images may exhibit degraded image… |
| Jul 20, 2016 | Class II | Z-2652-2016 | Software Design Change | After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur on gated CT helical reconstruction that is not planned at… |
| Jul 20, 2016 | Class II | Z-2658-2016 | Software Design Change | After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur on gated CT helical reconstruction that is not planned at… |
| Jul 20, 2016 | Class II | Z-2657-2016 | Software Design Change | After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur on gated CT helical reconstruction that is not planned at… |
| Jun 21, 2016 | Class II | Z-2113-2016 | Nonconforming Material/Component | Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack causing injury to patients, operators, by-standers and service personnel. |
| Jun 21, 2016 | Class II | Z-2115-2016 | Nonconforming Material/Component | Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack causing injury to patients, operators, by-standers and service personnel. |
| Jun 21, 2016 | Class II | Z-2114-2016 | Nonconforming Material/Component | Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack causing injury to patients, operators, by-standers and service personnel. |
| Apr 29, 2016 | Class II | Z-2380-2016 | Software design | Software issues found in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 products that could affect the performance of the equipment. |
| Apr 29, 2016 | Class II | Z-2385-2016 | Software design | Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the performance of the equipment. |
| Apr 29, 2016 | Class II | Z-2383-2016 | Software design | Software issues in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 and Ingenuity CT products that could affect the performance of the equipment. |
| Apr 29, 2016 | Class II | Z-2384-2016 | Software design | Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the performance of the equipment. |
| Apr 8, 2016 | Class II | Z-1875-2016 | Software design | The firm became aware of a problem where the system may not map Varian drive after CT user logout/login. |
| Apr 8, 2016 | Class II | Z-1872-2016 | Software design | The firm became aware of a problem where the system may not map Varian drive after CT user logout/login. |
| Apr 8, 2016 | Class II | Z-1873-2016 | Software design | The firm became aware of a problem where the system may not map Varian drive after CT user logout/login. |
| Apr 8, 2016 | Class II | Z-1874-2016 | Software design | The firm became aware of a problem where the system may not map Varian drive after CT user logout/login. |
| Apr 1, 2016 | Class II | Z-2117-2016 | Software design (manufacturing process) | Philips Healthcare received reports from the field that certain Ingenuity Core systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images. A patient rescan may be… |
| Apr 1, 2016 | Class II | Z-2118-2016 | Software design (manufacturing process) | Philips Healthcare received reports from the field that certain Ingenuity Core128 systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images. A patient rescan may be… |
| Apr 1, 2016 | Class II | Z-2116-2016 | Software design (manufacturing process) | Philips Healthcare received reports from the field that certain Brilliance 64 systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images. A patient rescan may be… |
| Mar 24, 2016 | Class II | Z-2366-2016 | Software change control | Software defect causing intermittently slow response of Host. |
| Mar 24, 2016 | Class II | Z-2371-2016 | Software change control | Software defect causing intermittently slow response of Host. |
| Mar 24, 2016 | Class II | Z-2372-2016 | Software change control | Software defect causing intermittently slow response of Host. |
| Mar 4, 2016 | Class II | Z-1506-2016 | Software design | The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90¿ or 180¿ relative to one another. However, certain gamma cameras allow for other relative detector angles. Data… |
| Feb 5, 2016 | Class II | Z-1355-2016 | Software design | The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices. |
| Feb 5, 2016 | Class II | Z-1351-2016 | Software design | The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices. |
| Feb 5, 2016 | Class II | Z-1356-2016 | Software design | The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices. |
| Feb 5, 2016 | Class II | Z-1354-2016 | Software design | The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices. |
| Oct 29, 2015 | Class II | Z-0548-2016 | Software design | Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion… |
| Oct 29, 2015 | Class II | Z-0547-2016 | Software design | Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion… |
The 5 latest of 50 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 10 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K042293 (Philips Medical Systems (Cleveland), Inc., 2004) has gone furthest, with 147 descendants of its own.
- 10 other devices also cite its predicate K012009.
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.
FDA decisions per year · JAK
27in 2025
2007high 30 (2014) · low 7 (2010)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
2007high 200 (2014) · low 27 (2007)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
2007high 51 (2010) · low 5 (2019)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
2007high 543 (2018) · low 76 (2007)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 Plus” is a Computed Tomography X-Ray System intended to produce 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, components and accessories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033326 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033326: Philips Plus Computed Tomography System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033326
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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