510(k) · Cleared
Recalled · Class II · 2025Brilliance Volume
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems (Cleveland), Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Jun 5, 2006 as substantially equivalent to K033326 (Philips Medical Systems, Inc., 2003) after a 61-day review. Its family tree reaches back 5 generations to 1993. 24 later devices descend from it. It has been recalled 61 times.
- Decided
- Jun 5, 2006
- Review
- 61 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 61
- Predicates
- 1
Its longest line of descent runs back 5 generations to K930090 (1993). 10 ancestors in all. 24 later devices descend from it, 8 citing it directly.
- Root · 5 generations backK930090 HelicatElscint, Inc. · 1993
- 4 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 3 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 2 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- 1 generation backK033326 Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc. · 2003 · Recalled
- This deviceK060937 Brilliance VolumePhilips Medical Systems (Cleveland), Inc. · 2006
- Descendant · cites it directly · 11 of its ownK131773 Brilliance IctPhilips Healthcare (Cleveland) · 2013
- Descendant · 2 generations on · 10 of its ownK133674 Philips Iqon Spectral CTPhilips Healthcare (Cleveland) · 2014 · Recalled
- Descendant · 3 generations on · 7 of its ownK163711 IQon Spectral CTPhilips Medical Systems (Cleveland), Inc. · 2017 · Recalled
- Descendant · 4 generations on · 6 of its ownK193454 IQon Spectral CTPhilips Medical Systems Nederland B.V. · 2020 · Recalled
- Descendant · 5 generations on · 5 of its ownK203020 Spectral CTPhilips Medical Systems Nederland B.V. · 2021 · Recalled
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
2008high 4 (2026) · low 0 (2016)2026
Most influential descendants
Showing 5 of 24 · See all- K131773Brilliance IctPhilips Healthcare (Cleveland) · 2013 · cites it directly11descendants
- K133674Philips Iqon Spectral CTPhilips Healthcare (Cleveland) · 2014 · 2 generations on10descendants
- K163711IQon Spectral CTPhilips Medical Systems (Cleveland), Inc. · 2017 · 3 generations on7descendants
- K193454IQon Spectral CTPhilips Medical Systems Nederland B.V. · 2020 · 4 generations on6descendants
- K203020Spectral CTPhilips Medical Systems Nederland B.V. · 2021 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −4 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −3 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −2 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| −1 | K033326 | Philips Plus Computed Tomography System | Philips Medical Systems, Inc. | 2003 | 131 |
| 0 (this device) | K060937 | Brilliance Volume | Philips Medical Systems (Cleveland), Inc. | 2006 | — |
| +1 | K131773 | Brilliance Ict | Philips Healthcare (Cleveland) | 2013 | — |
| +2 | K133674 | Philips Iqon Spectral CT | Philips Healthcare (Cleveland) | 2014 | 6 |
| +3 | K163711 | IQon Spectral CT | Philips Medical Systems (Cleveland), Inc. | 2017 | 2 |
| +4 | K193454 | IQon Spectral CT | Philips Medical Systems Nederland B.V. | 2020 | 6 |
| +5 | K203020 | Spectral CT | Philips Medical Systems Nederland B.V. | 2021 | 8 |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K033326 | Philips Plus Computed Tomography SystemSummary page 1…e Volume" CT scanner is of comparable type and substantially equivalent to the legally marketed devices currently in commercial distribution, namely: the Philips Plus in K033326. 4. Device Description The "Brilliance Volume" is a Whole Body Computed Tomography X-Ray System featuring a continuously rot… | 2003 |
What descends from it? (24)
See all 248 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131773 | Brilliance Ict | 2013 | 11 |
| K090462 | Brilliance Dual Energy Option | 2009 | 3 |
| K203216 | The Multimodality Advanced Vessel Analysis | 2020 | 1 |
| K162838 | Philips iCT CT System | 2017 | 1 |
| K113483 | Iterative Reconstruction Technique Software Application | 2012 | 1 |
| K133603 | Philips CT Dynamic Myocardial Perfusion (DMP) Application | 2014 | 0 |
| K123576 | Imr Software Application | 2013 | 0 |
| K081482 | CSBP-001A Body Organ Perfusion System | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 13, 2025 | Class II | Z-2599-2025 | 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-1990-2021 | 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… |
| Apr 13, 2021 | Class II | Z-1774-2021 | Under Investigation by firm | Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury |
| Apr 6, 2020 | Class II | Z-1921-2020 | Process control | The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems. |
| Apr 6, 2020 | Class II | Z-1922-2020 | Process control | The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems. |
| Feb 8, 2018 | Class II | Z-1409-2018 | 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-1408-2018 | Software design | Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities. |
| Nov 8, 2017 | Class II | Z-0332-2018 | 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… |
| Nov 8, 2017 | Class II | Z-0331-2018 | 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… |
| Jul 11, 2017 | Class II | Z-0402-2018 | Software design | Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acquisition, image volume and other… |
| Jul 11, 2017 | Class II | Z-0403-2018 | Software design | Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acquisition, image volume and other… |
| Dec 23, 2016 | Class II | Z-1058-2017 | Employee error | During a retrospective review of production documentation it was observed that the M6 Rotor Counterweight Bolt may have been improperly torqued. |
| Nov 25, 2016 | Class II | Z-1004-2017 | Employee error | Failure to correctly document the installation of four M12 Bolts into the system rotor. |
| Oct 13, 2016 | Class III | Z-0594-2017 | Labeling Change Control | The product label does not include the correct current rating. |
| Oct 13, 2016 | Class III | Z-0593-2017 | Labeling Change Control | The product label does not include the correct current rating. |
| Jun 21, 2016 | Class II | Z-2112-2016 | 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. |
| Apr 29, 2016 | Class II | Z-2382-2016 | Software design | Software issues found in v4.1 .3/4.1.5 in the Philips Brilliance iCT/ iCT SP products that could affect the performance of the equipment. |
| Apr 29, 2016 | Class II | Z-2381-2016 | Software design | Software issues in versions v4.1 .3/4.1.5 in the Philips Brilliance iCT) iCT SP products that, could affect the performance of the equipment. |
| 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-1352-2016 | 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-1353-2016 | 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-0545-2016 | 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-0546-2016 | 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… |
| Sep 6, 2015 | Class II | Z-1713-2016 | Radiation Control for Health and Safety Act | Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of view; (4) DoseRight… |
| Sep 6, 2015 | Class II | Z-1715-2016 | Radiation Control for Health and Safety Act | Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of view; (4) DoseRight… |
| Sep 6, 2015 | Class II | Z-1714-2016 | Radiation Control for Health and Safety Act | Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of view; (4) DoseRight… |
| Apr 13, 2015 | Class II | Z-1695-2015 | Other | A calibrated torque wrench malfunctioned at the supplier leading to possible incorrect torque of x-ray tube mounting fasteners. |
| Mar 16, 2015 | Class II | Z-1656-2015 | Employee error | The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so. |
| Mar 6, 2015 | Class II | Z-1767-2015 | Nonconforming Material/Component | The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes. |
| Mar 6, 2015 | Class II | Z-1768-2015 | Nonconforming Material/Component | The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes. |
| Mar 6, 2015 | Class II | Z-1769-2015 | Nonconforming Material/Component | The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes. |
| Feb 5, 2015 | Class II | Z-2256-2015 | Software change control | 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation missing for some images when manual contrast was administered. Dot artifact present, intermittently, after startup. Heart Rate measured value… |
| Feb 5, 2015 | Class II | Z-1359-2015 | Software design | Philips discovered that a software defect exists in marketed product wherein the sign indication of the longitudinal position of some types of scan is inverted. |
| Feb 5, 2015 | Class II | Z-2255-2015 | Software change control | 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation missing for some images when manual contrast was administered. Dot artifact present, intermittently, after startup. Heart Rate measured value… |
| Dec 8, 2014 | Class II | Z-0979-2015 | Process control | Improper assembly of the vertical motor/brake system may lead to uncommanded vertical motion. |
| Jul 31, 2014 | Class II | Z-0236-2015 | Radiation Control for Health and Safety Act | It was discovered that a software defect may result in the scanner not terminating the CT scan at the intended location. |
| Jul 27, 2014 | Class II | Z-2237-2014 | Software design | The following software issues have been identified in the affected products. Problem 1: When reopening a bookmark generated from processing a MUGA (Multi-Gated Acquisition) scan within the NM Cardiac Application, the ejection fraction… |
| Apr 1, 2014 | Class II | Z-1722-2014 | Component design/selection | A customer reported that the table top had become free floating. A Field Service Engineer (FSE) confirmed that the service latch had become disengaged. |
| Mar 27, 2014 | Class II | Z-1461-2014 | Nonconforming Material/Component | Block assembly-lock stop subframe of service latch was not manufactured to engineering specifications from the supplier, causing premature fracture of the threaded rod on the patient support service latch. As a result, the table top can… |
| Mar 11, 2014 | Class II | Z-1678-2014 | Software design | During SPECT reconstructions using Attenuation Correction and Scatter Correction, no Scatter Correction is being applied in the AutoSPECT Pro application on IntelliSpace Portal. In addition, resolution recovery is not applied correctly in… |
| Dec 9, 2013 | Class II | Z-0832-2014 | Software design | Patient images exhibited ring artifacts. |
| Oct 11, 2013 | Class II | Z-0335-2014 | Device Design | If the couch, with the footrest extension attached, is positioned where the table travel is within the bore of the gantry, and the user begins to lower the couch, the footrest extension can contact the gantry cover or come in contact with… |
| Jul 16, 2013 | Class II | Z-0831-2014 | Device Design | An artifact that resembles thrombus may appear on the image. |
| Dec 20, 2012 | Class II | Z-0945-2013 | Component design/selection | Philips Healthcare received reports from the field stating the patient table on a system had an unexpected downward movement while a patient was on the table. Philips has determined the cause was a malfunction of the vertical brake. |
| Jul 2, 2012 | Class II | Z-2035-2012 | Process control | Philips Healthcare was notified that several of the sixteen bolts securing the brackets which support the carbon table top on various models of their Brilliant CT scanner have been found to be defective and the bolt heads may break off. |
| May 23, 2012 | Class II | Z-1987-2012 | Software design | The Intellispace Portal software and Extended Brillance Workspace software may have significantly different results in the colors and size of the affected area when the customer uses the "Time Sensitive" and "Time Insensitive" methods. |
| May 23, 2012 | Class II | Z-1988-2012 | Software design | Philips is issuing a software update to the Intellispace Portal systems to address a number of non-conformances. The most frequent and severe non-conformance identified involves the portal setting of "PAC Integration". This setting has a… |
| May 22, 2012 | Class II | Z-2000-2012 | Software design | In the Multi-Modality Tumor Tracking application, when changing the contours of the lesion using the editing mode "edit contour" tool, the measurements are not recalculated causing discrepancies with the lesion measurements. |
| May 7, 2012 | Not classified | Z-1688-2012 | Nonconforming Material/Component | On 3/5/2012, Philips Healthcare was notified of one incident involving a Brilliance iCT scanner that resulted in damage to the gantry and slight injury to the user when the heat exchanger detached from the cooling unit due to some missing… |
| May 7, 2012 | Class II | Z-1791-2012 | Software design | Philips is issuing a software update (version 3.2.4) to the Brilliance iCT and iCT SP systems currently running software version 3.2.0, 3.2.1 or 3.2.3, addressing a number of non-conformances. A review was conducted of all nonconformances… |
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 13 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K131773 (Philips Healthcare (Cleveland), 2013) has gone furthest, with 11 descendants of its own.
- 8 other devices also cite its predicate K033326.
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 "Brilliance Volume" 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, components and accessories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060937 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060937: Brilliance Volume.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060937
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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