510(k) · Cleared
Recalled · Class II · 2025MX8000 Idt CT System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Marconi Medical Systems, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Sep 13, 2001 as substantially equivalent to K982060 (Elscint, Inc., 1998) and 1 other predicate after a 78-day review. Its family tree reaches back 3 generations to 1993. 263 later devices descend from it. It has been recalled 61 times.
- Decided
- Sep 13, 2001
- Review
- 78 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 61
- Predicates
- 2
Its longest line of descent runs back 3 generations to K930090 (1993). 8 ancestors in all. 263 later devices descend from it, 11 citing it directly.
- Root · 3 generations backK930090 HelicatElscint, Inc. · 1993
- 2 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 1 generation backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- This deviceK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001
- Descendant · cites it directly · 214 of its ownK033326 Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc. · 2003 · Recalled
- 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 · cites it directly · 87 of its ownK032036 Gemini 16Philips Medical Systems (Cleveland), Inc. · 2003 · Recalled
Showing 5 of 263 descendants. See all descendants
Descendants cleared per year
2003high 35 (2025) · low 2 (2010)2026
Most influential descendants
Showing 5 of 263 · See all- K033326Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc. · 2003 · cites it directly214descendants
- 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
- K032036Gemini 16Philips Medical Systems (Cleveland), Inc. · 2003 · cites it directly87descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −2 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −1 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| 0 (this device) | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | — |
| +1 | K033326 | Philips Plus Computed Tomography System | Philips Medical Systems, Inc. | 2003 | 131 |
| +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 |
| +1 | K032036 | Gemini 16 | Philips Medical Systems (Cleveland), Inc. | 2003 | 2 |
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 |
|---|---|---|
| 2003 | 3 | 0 |
| 2004 | 7 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 7 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 6 | 0 |
| 2013 | 6 | 0 |
| 2014 | 9 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 12 | 0 |
| 2018 | 14 | 0 |
| 2019 | 9 | 0 |
| 2020 | 22 | 0 |
| 2021 | 19 | 0 |
| 2022 | 22 | 0 |
| 2023 | 20 | 0 |
| 2024 | 19 | 0 |
| 2025 | 35 | 0 |
| 2026 | 26 | 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 |
|---|---|---|---|
| * | K982060 | Volumax CT Imaging SystemSummary page 2…f comparable type and substantially equivalent to the legally marketed devices currently in commercial distribution, namely: e Mx8000 (initially identified as Volumax), K982060 e Mx8000 v5.0, K010817 ' 6. Safety and Effectiveness Considerations The safety of the device is assured by adherence to GMP pr… | 1998 |
| * | K010817 | MX8000 V5.0 CT SystemSummary page 2…bstantially equivalent to the legally marketed devices currently in commercial distribution, namely: e Mx8000 (initially identified as Volumax), K982060 e Mx8000 v5.0, K010817 ' 6. Safety and Effectiveness Considerations The safety of the device is assured by adherence to GMP practices and to Internati… | 2001 |
What descends from it? (263)
See all 26311 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033326 | Philips Plus Computed Tomography System | 2003 | 214 |
| K042293 | Brilliance CT, Private Practice CV Configuration, CT Scanner | 2004 | 147 |
| K032036 | Gemini 16 | 2003 | 87 |
| K041955 | Gemini Pet/CT Imaging System | 2004 | 65 |
| K033357 | Acqsim-Multislice-CT, Model 453567042271 | 2004 | 10 |
| K023785 | Lung Nodule Assessment and Comparison Option | 2003 | 10 |
| K033677 | Brain Perfusion Option | 2004 | 3 |
| K091195 | Philips MX 16 Slice CT System PHASE11, Model 9896 056 56511 | 2009 | 1 |
| K041218 | Griffin Spect/CT Imaging System | 2004 | 1 |
| K090173 | Neuviz 16 Multi-Slice CT Scanner System | 2009 | 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-2596-2025 | 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-1981-2021 | 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-0548-2019 | 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-0545-2019 | 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-0547-2019 | 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-0546-2019 | 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-1142-2019 | 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-2175-2018 | 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… |
| Mar 30, 2018 | Class II | Z-2176-2018 | 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 8, 2018 | Class II | Z-1412-2018 | 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-1415-2018 | Software design | Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities. |
| Jul 20, 2016 | Class II | Z-2656-2016 | 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-2655-2016 | 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… |
| Mar 24, 2016 | Class II | Z-2370-2016 | Software change control | Software defect causing intermittently slow response of Host. |
| Mar 24, 2016 | Class II | Z-2369-2016 | 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… |
| Sep 14, 2015 | Class II | Z-0173-2016 | Software design | The firm discovered Ring/Dot artifact due to X-ray measurement error. |
| Mar 16, 2015 | Class II | Z-1651-2015 | 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 16, 2015 | Class II | Z-1652-2015 | 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 16, 2015 | Class II | Z-1653-2015 | 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 16, 2015 | Class II | Z-1654-2015 | 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 16, 2015 | Class II | Z-1655-2015 | 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-1766-2015 | 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-1765-2015 | 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-1793-2015 | 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. |
| 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 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… |
| Aug 30, 2013 | Class II | Z-0013-2014 | Software design | There are artifacts appearing on the Tracker images during threshold-triggered bolus scans with protocols using a Rotation Time of 0.4 seconds. |
| Jul 5, 2013 | Class II | Z-2210-2013 | Component design/selection | The patient support may move in an unintended manner if the footswitch cover impinges on the footswitch. |
| Mar 12, 2013 | Class II | Z-1338-2013 | Use error | Philips Healthcare received a report from the field stating when they viewed the CTDIVol information from the PACS system, the calculations were too high. Instead of storing the CTDIVol value for each slice in the DICOM tag, the system… |
| 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. |
| Oct 24, 2012 | Class II | Z-0881-2013 | Software design | Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was… |
| Aug 28, 2012 | Class III | Z-2404-2012 | Software change control | Philips was notified that the system logout in software version 2.3.6 is now longer and may sometimes fail to logout, requiring a forced system restart or hard shutdown with the power button. |
| Aug 21, 2012 | Class II | Z-2451-2012 | Nonconforming Material/Component | A bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry. |
| Aug 3, 2012 | Class II | Z-2245-2012 | Device Design | The patient support may move in an unintended manner if the foot switch cover becomes damaged and impinges on the foot switch. |
| 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-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 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 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. |
| Mar 26, 2012 | Not classified | Z-1693-2012 | Nonconforming Material/Component | Component defect. Following their receipt of a customer complaint, Philips Medical determined that the metal blocks which support the scissor slide rails underneath the scanning table (couch) of several of the firm's CT scanning systems… |
| Mar 26, 2012 | Not classified | Z-1692-2012 | Nonconforming Material/Component | Component defect. Following their receipt of a customer complaint, Philips Medical determined that the metal blocks which support the scissor slide rails underneath the scanning table (couch) of several of the firm's CT scanning systems… |
| Mar 26, 2012 | Not classified | Z-1691-2012 | Nonconforming Material/Component | Component defect. Following their receipt of a customer complaint, Philips Medical determined that the metal blocks which support the scissor slide rails underneath the scanning table (couch) of several of the firm's CT scanning systems… |
| Mar 26, 2012 | Not classified | Z-1690-2012 | Nonconforming Material/Component | Component defect. Following their receipt of a customer complaint, Philips Medical determined that the metal blocks which support the scissor slide rails underneath the scanning table (couch) of several of the firm's CT scanning systems… |
| Sep 15, 2011 | Not classified | Z-0182-2012 | Software design | A problem related to a software error has been detected in the Philips Multiple Gated Radionuclide Angiocardiography (MUGA) application. A false negative interpretation due to a falsely elevated ejection fraction or a false positive… |
| Dec 10, 2010 | Not classified | Z-1669-2011 | Other | Philips Medical Systems has decided to recall the patient support vertical brake hub in all its Brilliance systems due to the collapse in the vertical direction. The short key connecting the vertical brake hub to the motor shaft can… |
| Jul 27, 2010 | Not classified | Z-0133-2011 | Software change control | Philips Healthcare has decided to recall the Computed Tomography X-Ray System MX 8000 IDT due to the fact that the software upgrade for the MX 8000 IDT 16 v4.2.1 may not provide the optional collimation of 4x4.5 (18mm). If the customer… |
| Oct 3, 2009 | Not classified | Z-1819-2011 | Other | During an FDA inspection on 10/1/2010 the firm was notified by FDA that their field action they initiated in Oct 2009, constituted a recall. The firm determined that the functional analysis feature in the Comprehensive Cardiac Analysis… |
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 8 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K033326 (Philips Medical Systems, Inc., 2003) has gone furthest, with 214 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.
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 Mx8000 IDT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
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/K012009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012009: MX8000 Idt CT System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012009
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026