510(k) · Cleared
Recalled · Class II · 2021MX8000 V5.0 CT System
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 15, 2001 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 264 later devices descend from it. It has been recalled 12 times.
- Decided
- Jun 15, 2001
- Review
- 88 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 12
- Predicates
- 0
264 later devices descend from it, 3 citing it directly.
- This deviceK010817 MX8000 V5.0 CT SystemPhilips Medical Systems (Cleveland), Inc. · 2001
- Descendant · cites it directly · 263 of its ownK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- Descendant · cites it directly · 214 of its ownK033326 Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 147 of its ownK042293 Brilliance CT, Private Practice CV Configuration, CT ScannerPhilips Medical Systems (Cleveland), Inc. · 2004 · Recalled
- Descendant · 3 generations on · 92 of its ownK130159 Qlab Quantification Software Heart ModelPhilips Health Care · 2013
- Descendant · 4 generations on · 91 of its ownK132165 Qlab Quantification SoftwarePhilips Ultrasound, Inc. · 2013 · Recalled
Showing 5 of 264 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 264 · See all- K012009MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · cites it directly263descendants
- 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 · 2 generations on147descendants
- K130159Qlab Quantification Software Heart ModelPhilips Health Care · 2013 · 3 generations on92descendants
- K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc. · 2013 · 4 generations on91descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010817 | MX8000 V5.0 CT System | Philips Medical Systems (Cleveland), Inc. | 2001 | — |
| +1 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| +1 | K033326 | Philips Plus Computed Tomography System | Philips Medical Systems, Inc. | 2003 | 131 |
| +2 | K042293 | Brilliance CT, Private Practice CV Configuration, CT Scanner | Philips Medical Systems (Cleveland), Inc. | 2004 | 1 |
| +3 | K130159 | Qlab Quantification Software Heart Model | Philips Health Care | 2013 | — |
| +4 | K132165 | Qlab Quantification Software | Philips Ultrasound, Inc. | 2013 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (264)
See all 2643 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 1, 2021 | Class II | Z-1979-2021 | 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… |
| Mar 16, 2015 | Class II | Z-1647-2015 | 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. |
| 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. |
| 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. |
| Jun 3, 2011 | Not classified | Z-2914-2011 | Device Design | Philips Medical Systems decided to conduct a recall/field correction of the patient support vertical brake hub component in all of their CT MX8000 Dual v. Exp Computed Tomography X-Ray System scanners due to a component defect which could… |
| Sep 23, 2008 | Not classified | Z-0597-2009 | Process control | The product is being recalled because the patient support may travel downwards without being commanded to move. |
| Nov 6, 2006 | Not classified | Z-0014-2007 | Other | A potential anomaly was identified on the CT subsytem, which could result in the radiation dose being different than the calculated dose reported to the operator. |
| Dec 27, 2005 | Class II | Z-2709-2014 | Device Design | The system has a gap that can appear between the upper and lower tilt stand covers. The fingers may be squeezed if a person was to place them in this region while the gantry was tilting from an angle to zero tilt angle. |
| Mar 11, 2005 | Not classified | Z-1414-05 | Other | When two product applications called Flip and Secondary Capture are used together, it is possible for image orientation labels to be incorrect. |
| Mar 11, 2005 | Not classified | Z-1410-05 | Other | When two product applications called Flip and Secondary Capture are used together, it is possible for image orientation labels to be incorrect. |
| Mar 11, 2005 | Not classified | Z-1412-05 | Other | When two product applications called Flip and Secondary Capture are used together, it is possible for image orientation labels to be incorrect. |
| Apr 2, 2003 | Not classified | Z-0836-03 | Other | Patient images may be incorrectly stored in the archive directory of a different patient. |
The 5 latest of 12 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K012009 (Marconi Medical Systems, Inc., 2001) has gone furthest, with 263 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
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 | — |
https://510kreport.com/device/K010817 · printed Nov 5, 2026
Cite this page
510(k) Report. “K010817: MX8000 V5.0 CT System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K010817
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026