Biograph Horizon
Siemens Medical Solution USA, Inc.The Biograph Horizon is a medical imaging system that combines positron emission tomography (PET) and computed tomography (CT) to provide detailed metabolic and anatomical images of the body. It helps clinicians in detecting, diagnosing, and monitoring diseases such as cancer, cardiovascular, and neurological disorders by fusing high-resolution functional and anatomical data, thereby improving treatment planning and clinical decision-making.
Intended Use
The Biograph Horizon systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners providing registration and fusion of high resolution physiologic and anatomic information for oncologic, neurologic, and cardiologic evaluations.
Technology
The device combines multi-slice CT and PET scanners with independent CT and PET functionality, incorporating advanced software features such as OncoFreeze AI for motion correction, CardioFreeze, FlowMotion Multi-Parametric PET AI, and QualityGuard for quality control. The software manages patient data, image reconstruction, and fusion of PET/CT images, along with scatter correction and fast attenuation correction maps.
Performance
Performance testing followed NEMA NU2-2018 standards demonstrating image resolution, sensitivity, count rate, scatter fraction, and co-registration accuracy meeting predefined acceptance criteria. Additional validation was performed on AI features for motion correction, and the device showed improvements in image quality and workflow efficiency.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/18/2019
2 months - 2
FDA Approval
2/12/2020
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