# K083498: Philips Model MX 16 Slice CT System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Dec 17, 2008 after 22 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 5 (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.
No later device cites it as a predicate yet.
0 of 10 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.

## Recalls of this device
- 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
- Jul 22, 2013 · Class II · Z-0019-2014: A pinch point at the end of the table top can cause injury.
- Dec 19, 2012 · Class II · Z-0899-2013: The four screws that secure the patient table top to the carrier became loose, which caused the table top to detach.
- 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/K083498
Methodology: https://510kreport.com/methodology