# K042293: Brilliance CT, Private Practice CV Configuration, CT Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Sep 8, 2004 after 15 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K930090 (1993). 10 ancestors in all.
147 later devices descend from it; 6 cite it directly.
0 of 158 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033326: Philips Plus Computed Tomography System, Philips Medical Systems, Inc. (2003) Summary page 2.
- K012009: MX8000 Idt CT System, Marconi Medical Systems, Inc. (2001) Summary page 2.

## Most influential descendants
- K130159: Qlab Quantification Software Heart Model (2013), 92 descendants of its own
- K132165: Qlab Quantification Software (2013), 91 descendants of its own
- K062650: EP Navigator Software (2006), 49 descendants of its own
- K171314: QLAB Advanced Quantification Software (2017), 45 descendants of its own
- K181264: QLAB Advanced Quantification Software (2018), 44 descendants of its own

## Recalls of this device
- Jun 24, 2019 · Class II · Z-2191-2019: In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been 

## Indications for use
The Philips Brilliance CT in the Private Practice CV configuration is a Computed Tomography X-Ray System intended to produce images of the heart, cardiovascular (including pulmonary veins) and peripheral vascular systems (including the carotids, renals, aorta, iliac, and other distal vessels imaged by angiographic run-off procedures) 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/K042293
Methodology: https://510kreport.com/methodology