510(k) · Cleared
Recalled · Class II · 2021Acqsim-Multislice-CT, Model 453567042271
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 Jan 9, 2004 as substantially equivalent to K001088 (Philips Medical Systems (Cleveland), Inc., 2000) and 2 other predicates after an 81-day review. Its family tree reaches back 4 generations to 1993. 10 later devices descend from it. It has been recalled 50 times.
- Decided
- Jan 9, 2004
- Review
- 81 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 50
- Predicates
- 3
Its longest line of descent runs back 4 generations to K930090 (1993). 10 ancestors in all. 10 later devices descend from it, 3 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 deviceK033357 Acqsim-Multislice-CT, Model 453567042271Philips Medical Systems (Cleveland), Inc. · 2004
- Descendant · cites it directly · 6 of its ownK171850 Philips CT Big BorePhilips Medical Systems (Cleveland), Inc. · 2017 · Recalled
- Descendant · 2 generations on · 3 of its ownK240844 Spectral CT 7500 RTPhilips Medical Systems Technologies, Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK181797 Philips CT Big Bore Sliding Gantry ConfigurationPhillips Medical Systems (Cleveland), Inc. · 2018
- Descendant · cites it directly · 1 of its ownK160611 P-ArtisP-Cure, Ltd. · 2016
- Descendant · 3 generations on · 0 of its ownK253649 Spectral CT Verida FamilyPhilips Medical Systems Technologies, Ltd. · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
2008high 2 (2025) · low 0 (2009)2026
Most influential descendants
Showing 5 of 10 · See all- K171850Philips CT Big BorePhilips Medical Systems (Cleveland), Inc. · 2017 · cites it directly6descendants
- K240844Spectral CT 7500 RTPhilips Medical Systems Technologies, Ltd. · 2024 · 2 generations on3descendants
- K181797Philips CT Big Bore Sliding Gantry ConfigurationPhillips Medical Systems (Cleveland), Inc. · 2018 · 2 generations on1descendant
- K160611P-ArtisP-Cure, Ltd. · 2016 · cites it directly1descendant
- K253649Spectral CT Verida FamilyPhilips Medical Systems Technologies, Ltd. · 2026 · 3 generations on0descendants
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) | K033357 | Acqsim-Multislice-CT, Model 453567042271 | Philips Medical Systems (Cleveland), Inc. | 2004 | — |
| +1 | K171850 | Philips CT Big Bore | Philips Medical Systems (Cleveland), Inc. | 2017 | 14 |
| +2 | K240844 | Spectral CT 7500 RT | Philips Medical Systems Technologies, Ltd. | 2024 | — |
| +2 | K181797 | Philips CT Big Bore Sliding Gantry Configuration | Phillips Medical Systems (Cleveland), Inc. | 2018 | — |
| +1 | K160611 | P-Artis | P-Cure, Ltd. | 2016 | — |
| +3 | K253649 | Spectral CT Verida Family | Philips Medical Systems Technologies, Ltd. | 2026 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K001088 | Ultrasim CT SystemSummary page 2…e-CT" CT scanner is of comparable type and substantially equivalent to the legally marketed devices currently in commercial distribution, namely: * AcQSim-CT, K001088 * Mx8000 IDT, K012009 · Mx8000v5.0, K010817 6. Safety and Effectiveness Considerations The safety of the device… | 2000 |
| * | K012009 | MX8000 Idt CT SystemSummary page 2…able type and substantially equivalent to the legally marketed devices currently in commercial distribution, namely: * AcQSim-CT, K001088 * Mx8000 IDT, K012009 · Mx8000v5.0, K010817 6. Safety and Effectiveness Considerations The safety of the device is assured by adherence to G… | 2001 |
| * | K010817 | MX8000 V5.0 CT SystemSummary page 2…equivalent to the legally marketed devices currently in commercial distribution, namely: * AcQSim-CT, K001088 * Mx8000 IDT, K012009 · Mx8000v5.0, 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? (10)
3 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-1983-2021 | 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 28, 2018 | Class II | Z-2273-2018 | Other | A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users. |
| Feb 8, 2018 | Class II | Z-1411-2018 | 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-1410-2018 | Software design | Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities. |
| Jan 3, 2018 | Class II | Z-0839-2018 | Under Investigation by firm | Software issues including: Software errors that may result in Extended Field of View check message not displayed when Field of View is set >600 mm for a paused scan; Request for change to automatically turn on the center x/y 0 setting and… |
| Jan 3, 2018 | Class II | Z-0840-2018 | Under Investigation by firm | Software issues including: Software errors that may result in Extended Field of View check message not displayed when Field of View is set >600 mm for a paused scan; Request for change to automatically turn on the center x/y 0 setting and… |
| Feb 23, 2017 | Class II | Z-1493-2017 | Software design | Philips identified a 4D CT pulmonary phase issue on Brilliance BigBore Oncology/Radiology CT with 4.2.0 software version through customer complaints. When the user performs a retrospective respiratory gated 4D CT scan with the Bellows… |
| Feb 23, 2017 | Class II | Z-1492-2017 | Software design | When the user performs a retrospective respiratory gated 4D CT scan with the Bellows pulmonary gating device, the CT images might be reconstructed at a single phase, while the annotations on the images incorrectly indicate that the… |
| Jul 20, 2016 | Class II | Z-2654-2016 | 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-2653-2016 | 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-2111-2016 | 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 and cause injury to patients, operators, by standers or service personnel. |
| Jun 14, 2016 | Class II | Z-2110-2016 | Nonconforming Material/Component | Socket Head Cap Screws (SHCS) used in the Z-Axis Adjustment Plate were found to be made of stainless steel rather than the specified alloy steel. |
| Jun 14, 2016 | Class II | Z-2109-2016 | Nonconforming Material/Component | Socket Head Cap Screws (SHCS) used in the Z-Axis Adjustment Plate were found to be made of stainless steel rather than the specified alloy steel. |
| Mar 24, 2016 | Class II | Z-2367-2016 | Software change control | Software defect causing intermittently slow response of Host. |
| Mar 24, 2016 | Class II | Z-2368-2016 | Software change control | Software defect causing intermittently slow response of Host. |
| Sep 14, 2015 | Class II | Z-0177-2016 | Software design | The firm discovered Ring/Dot artifact due to X-ray measurement error. |
| Mar 16, 2015 | Class II | Z-1648-2015 | 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-1763-2015 | 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-1764-2015 | 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. |
| 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… |
| Dec 19, 2013 | Class II | Z-1745-2014 | Nonconforming Material/Component | During internal testing, the Brilliance CT Big Bore was found to be out of tolerance for radio frequency emissions. Specifically, at the 48MHZ frequency, the testing indicated the Brilliance CT Big Bore was 3.5dB uV/meter higher than the… |
| Dec 4, 2013 | Class II | Z-0801-2014 | Software design | Machine Name in TumorLOC Basic Mode is obscured. When TumorLOC is in Basic Mode and Set Vertical Laser equals Yes, the Machine Name label and field are covered by the controls above it. The Machine Name cannot be viewed or changed. |
| 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. |
| 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-0880-2013 | 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 31, 2012 | Class II | Z-2666-2014 | Software design | Philips Healthcare received a complaint stating the system opens e-stop while sitting idle causing all movements and scan to stop. The problem has only occurred one time when the scan was out of Ready for Scan or scanning mode. |
| 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. |
| 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-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-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… |
| Dec 13, 2011 | Not classified | Z-0946-2012 | Software design | The Block and Multi Leaf Collimator (MLC) shape is not propagated to the beam that is modified by the Oppose operation. The contours can appear with the incorrect color in the Beam's Eye View Viewer, resulting in organs being incorrectly… |
| Oct 7, 2011 | Not classified | Z-0845-2012 | Software design | The Common Image Reconstruction System (CIRS) on the affected Brilliance Systems encounters an error and requires reboot of the system. The unit failed to initialize axial scan due to timeout that occurred waiting for "READY" state |
| Sep 22, 2011 | Not classified | Z-0334-2012 | Software design | Software errors. A number of non-conformances were found for the Brilliance Big Bore and Brilliance 64 Computed Tomography X-ray Systems equipped with software version; 3.5 Beta1. The non-conformances stem from software errors identified… |
| Aug 29, 2011 | Not classified | Z-0777-2012 | Nonconforming Material/Component | Software errors. A number of non-conformances were logged in during in-house testing and external validation testing of Brilliance 64, Brilliance Big Bore, and Ingenuity CT systems, equipped with software version 3.5 Beta 2. The… |
| Mar 7, 2011 | Not classified | Z-2207-2011 | Other | A program software error in the algorithm produces image artifacts that could possibly lead to a misdiagnosis of patients who have small metal implants. |
| Mar 7, 2011 | Class II | Z-0791-2014 | Software design | The DoseRight feature suggest a mAs based on the measured patient size, a reference size and a reference mAs. When scanning large children, the suggested mAs may be higher than clinicians would expect. |
| 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… |
| Nov 24, 2008 | Not classified | Z-0286-2010 | Process design | A leak between the Tube Interface and the Outlet Tube of the transducer for the Respiratory Gating System component may result in a failure of the device to produce respiratory correlated images. |
| Nov 24, 2008 | Not classified | Z-0287-2010 | Process design | A leak between the Tube Interface and the Outlet Tube of the transducer for the Respiratory Gating System component may result in a failure of the device to produce respiratory correlated images. |
| 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. |
| Sep 22, 2008 | Not classified | Z-0132-2009 | Process design | Images not correlated: A leak between the Tube Interface and the Outlet Tube of the transducer may result in a failure to produce respiratory correlated images. |
| Sep 27, 2007 | Not classified | Z-0121-2008 | Software design | The maximum intensity projection (MIP) images produced from respiratory gated images by the Tumor Localization (Tumor LOC) software application on Brilliance Big Bore CT scanners will be labeled incorrectly for certain patient… |
| Sep 10, 2007 | Not classified | Z-0366-2008 | Software design | Incorrect Measurement: Incorrect measurement will occur when the operator uses the distance or area measurement function, such as Graphic Tool line or ROI on zoomed and batch saved images from the Cardiac Viewer or Pulmonary Viewer and… |
| Jan 9, 2007 | Class II | Z-2678-2014 | Labeling design | When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in teh extended region are not accurate. |
| 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. |
| Oct 2, 2006 | Not classified | Z-0636-2007 | Other | Two conditions have been identified with the Philips Medical System Brilliance Bore ,version 2.2.1 Tumor Localization, that may lead the user to misinterpret the displayed data. |
| Apr 25, 2006 | Class II | Z-0400-2016 | Software design | Brilliance Big Bore- An anomaly was identified with software version 2.0 tumor localization application when printing work sheets. this causes information regarding relative locations of marked regions of interest on the patient work… |
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 11 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K171850 (Philips Medical Systems (Cleveland), Inc., 2017) has gone furthest, with 6 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 "AcQSim-Multislice-CT" 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/K033357 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033357: Acqsim-Multislice-CT, Model 453567042271.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033357
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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