# K091195: Philips MX 16 Slice CT System PHASE11, Model 9896 056 56511

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: May 27, 2009 after 34 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 8 (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). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012009: MX8000 Idt CT System, Marconi Medical Systems, Inc. (2001) Summary page 1.

## Most influential descendants
- K191136: Access CT (2019), 0 descendants of its own

## Recalls of this device
- May 1, 2021 · Class II · Z-1980-2021: 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
- Apr 20, 2016 · Class II · Z-2346-2016: The following issues have been found in MX 16-slice systems with software version 1.1.4.21426: 1. During the filming operation on MX16-slice console software, the clipboard used for copying and pastin
- Apr 20, 2016 · Class II · Z-2347-2016: The following issues have been found in MX 16-slice systems with software version 1.1.4.21426: 1. During the filming operation on MX16-slice console software, the clipboard used for copying and pastin
- Mar 6, 2015 · Class II · Z-1759-2015: 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-1760-2015: 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
- Oct 9, 2014 · Class II · Z-0190-2015: "The orientation of images is displayed incorrectly. When operator chooses gantry on the right side from operation console, and the patient position is HFDL, HFDR, FFDL or FFDR, the patient position p
- Aug 24, 2012 · Class II · Z-2386-2012: On August 24, 2012 the firm recalled the MX 16-slice after discovering that a bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tu
- Mar 10, 2011 · Not classified · Z-2059-2011: The Philips MX 16-slice CT scanners are subject to recall/field correction due to a problem encountered with the units when using the 'Combine Viewing' Option. The firm determined that inaccurate dime

## Indications for use
The Philips MX 16-slice CT system can be used as a Head and Whole Body Computed Tomography X-ray System featuring a continuously rotating x-ray tube and detector array with multislice capability up to 16 slices simultaneously. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients.

Source page: https://510kreport.com/device/K091195
Methodology: https://510kreport.com/methodology