Precise Image
Philips Medical Systems Nederland, B.V.Precise Image is an AI-powered reconstruction software for computed tomography (CT) systems developed by Philips. It produces high-quality images with lower radiation dose and noise, improving the detectability of low contrast features. This helps clinicians obtain clearer diagnostic images from CT scans of the head, body, and vascular regions, enhancing patient safety by reducing radiation exposure while maintaining image quality.
Intended Use
The Precise Image is a reconstruction software application for a Computed Tomography X-Ray System intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. It uses an Artificial Intelligence powered reconstruction algorithm designed for low radiation dose, lower noise, and improved low contrast detectability.
Technology
Precise Image is based on Artificial Intelligence using Convolutional Neural Networks (CNN) to reconstruct CT images. It provides image appearance similar to traditional filtered back projection (FBP) but with lower dose and noise, and improved low contrast detection. The software has user-adjustable settings to tune dose reduction and image quality.
Performance
The device underwent non-clinical verification and validation testing, including image quality assessments, risk analysis, and compliance with international FDA recognized standards. Clinical performance was evaluated via comparative image studies reviewed by board-certified radiologists, demonstrating substantial equivalence to predicate devices with improved noise reduction and low contrast detectability.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/15/2021
10 months - 2
FDA Approval
1/14/2022
Other devices from Philips Medical Systems Nederland, B.V.
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.