# K033357: Acqsim-Multislice-CT, Model 453567042271

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Jan 9, 2004 after 81 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 50 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K930090 (1993). 10 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001088: Ultrasim CT System, Philips Medical Systems (Cleveland), Inc. (2000) Summary page 2.
- K012009: MX8000 Idt CT System, Marconi Medical Systems, Inc. (2001) Summary page 2.
- K010817: MX8000 V5.0 CT System, Philips Medical Systems (Cleveland), Inc. (2001) Summary page 2.

## Most influential descendants
- K171850: Philips CT Big Bore (2017), 6 descendants of its own
- K240844: Spectral CT 7500 RT (2024), 3 descendants of its own
- K181797: Philips CT Big Bore Sliding Gantry Configuration (2018), 1 descendant of its own
- K160611: P-Artis (2016), 1 descendant of its own
- K253649: Spectral CT Verida Family (2026), 0 descendants of its own

## Recalls of this device
- May 1, 2021 · Class II · Z-1983-2021: 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
- Mar 28, 2018 · Class II · Z-2273-2018: 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 user
- Feb 8, 2018 · Class II · Z-1411-2018: 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: 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: 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 automaticall
- Jan 3, 2018 · Class II · Z-0840-2018: 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 automaticall
- Feb 23, 2017 · Class II · Z-1493-2017: 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
- Feb 23, 2017 · Class II · Z-1492-2017: 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 image
- Jul 20, 2016 · Class II · Z-2654-2016: 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 r
- Jul 20, 2016 · Class II · Z-2653-2016: 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 r
- Jun 21, 2016 · Class II · Z-2111-2016: 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 
- Jun 14, 2016 · Class II · Z-2110-2016: 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: 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 defect causing intermittently slow response of Host.
- Mar 24, 2016 · Class II · Z-2368-2016: Software defect causing intermittently slow response of Host.
- Sep 14, 2015 · Class II · Z-0177-2016: The firm discovered Ring/Dot artifact due to X-ray measurement error.
- Mar 16, 2015 · Class II · Z-1648-2015: 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: 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, overh
- Mar 6, 2015 · Class II · Z-1764-2015: 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, overh
- Dec 8, 2014 · Class II · Z-0979-2015: Improper assembly of the vertical motor/brake system may lead to uncommanded vertical motion.
- Apr 1, 2014 · Class II · Z-1722-2014: 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: 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 l
- Dec 19, 2013 · Class II · Z-1745-2014: 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 Bo
- Dec 4, 2013 · Class II · Z-0801-2014: 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 Na
- Aug 30, 2013 · Class II · Z-0013-2014: 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: 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 ma
- Oct 24, 2012 · Class II · Z-0880-2013: 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 
- Aug 31, 2012 · Class II · Z-2666-2014: 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 Read
- Aug 3, 2012 · Class II · Z-2245-2012: 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: 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 defecti
- Mar 26, 2012 · Not classified · Z-1691-2012: 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 sever
- Mar 26, 2012 · Not classified · Z-1692-2012: 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 sever
- Mar 26, 2012 · Not classified · Z-1693-2012: 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 sever
- Dec 13, 2011 · Not classified · Z-0946-2012: 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, 
- Oct 7, 2011 · Not classified · Z-0845-2012: 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 occ
- Sep 22, 2011 · Not classified · Z-0334-2012: 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
- Aug 29, 2011 · Not classified · Z-0777-2012: 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 soft
- Mar 7, 2011 · Not classified · Z-2207-2011: 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: 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: 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 
- Nov 24, 2008 · Not classified · Z-0286-2010: 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: 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: 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: 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: 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 incor
- Sep 10, 2007 · Not classified · Z-0366-2008: 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 Car
- Jan 9, 2007 · Class II · Z-2678-2014: 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: 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: 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: 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 region

## Indications for use
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.

Source page: https://510kreport.com/device/K033357
Methodology: https://510kreport.com/methodology