# K160147: CT TrueView

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Aug 10, 2016 after 202 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K974367 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042334: Allura 3D-CA, Release 1, Philips Medical Systems North America Co. (2004) Summary page 4.

## Indications for use
CT TrueView assists physicians during cardio-vascular interventions when analyzing 2D images by segmenting a previously acquired 3D CT to create a 3D model of the coronary vessel tree. CT TrueView supports the physician navigating a catheter or guide wire through the coronary arteries by providing a composite image that combines a 2D X-ray exposure image with a CT based 3D visualization of the heart and/or coronaries. CT TrueView is suitable for use with the adult human population.

Source page: https://510kreport.com/device/K160147
Methodology: https://510kreport.com/methodology