Precise Position
Philips Healthcare (Suzhou) Co., Ltd.Precise Position is an AI-enabled accessory for Philips Incisive CT systems that assists technologists in accurately positioning patients before CT scans. It uses a ceiling-mounted camera to detect patient orientation, determine the scan range, and automatically center the patient's anatomy. This reduces positioning time and enhances accuracy for head, chest, abdomen, and pelvic CT imaging, ultimately improving imaging workflow and patient comfort.
Intended Use
The Precise Position is intended for use with Philips Incisive CT systems to guide patient orientation identification, surview range recommendation, automatic centering of patient anatomy, and providing visual images of the patient on the table for CT imaging of the head, chest, abdomen, pelvis, and combinations thereof. Patients younger than 16 years are not supported.
Technology
The device integrates a ceiling-mounted camera with color and depth functions, connected via hybrid USB cable to the CT gantry for power and data transmission. It uses AI based on a Convolutional Neural Network to detect patient joints, orientation, scan range, and anatomy center, assisting in automatic patient positioning before CT scanning.
Performance
Performance testing included compliance with IEC 60601-1, IEC 60601-1-2, ISO 14971, and IEC 62304 standards. Clinical evaluation tested 80 patient scan positions, showing up to 23% reduction in positioning time, 50% improvement in vertical centering accuracy, and 70% improvement in positioning consistency. The device was found safe and effective with no additional clinical risks identified.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/30/2020
6 months - 2
FDA Approval
6/17/2021
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