FDA Radiology AI Devices

Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.

The Biograph Trinion is a combined PET/CT imaging system designed to provide high-resolution fusion of metabolic and anatomical information. It assists healthcare professionals in detecting, diagnosing, staging, and managing diseases such as cancer, cardiovascular disorders, and neurological conditions. The system also supports radiotherapy planning and interventional procedures, enhancing diagnostic accuracy and patient care.

FDA #
K251561
Product Code
KPS

The Biograph Vision and Biograph mCT PET/CT systems by Siemens are advanced imaging devices combining positron emission tomography (PET) and computed tomography (CT). These systems help clinicians detect and diagnose various conditions by providing detailed molecular and anatomical images, facilitating better patient management.

FDA #
K251671
Product Code
KPS

The Symbia Pro.specta VA30A Family by Siemens is a hybrid SPECT/CT imaging system designed for healthcare professionals to help detect, localize, diagnose, and monitor various diseases including cardiovascular, neurological disorders, and cancer. It combines physiological imaging from SPECT with anatomical imaging from CT, enabling accurate assessment and radiotherapy planning. The device also supports low dose lung cancer screening and advanced image analysis software to assess and quantify pathologies.

FDA #
K243186
Product Code
KPS

The Biograph VK10 is a combined Positron Emission Tomography (PET) and Computed Tomography (CT) scanner that provides fused images of both physiological function and anatomical structure. It assists healthcare providers in detecting, localizing, diagnosing, staging, and restaging various diseases such as cancer, cardiovascular and neurological disorders. The system supports single modality and combined PET/CT imaging and can aid in treatment planning and lung cancer screening in high-risk populations.

FDA #
K233677
Product Code
KPS

The Biograph Vision.X and Biograph Vision.X Edge are advanced combined PET and CT scanners that provide high-resolution images by fusing metabolic and anatomical information. These systems assist healthcare professionals in detecting, diagnosing, and monitoring diseases such as cancer, cardiovascular and neurological disorders, and support treatment planning and interventional procedures.

FDA #
K231833
Product Code
KPS

The Biograph Vision and Biograph mCT PET/CT systems from Siemens are advanced imaging machines that combine CT and PET technologies to produce high-resolution images showing both anatomical structures and physiological functions. These systems help healthcare professionals detect, localize, diagnose, and stage various diseases including cancer, cardiovascular, and neurological disorders, and also assist with radiotherapy and interventional procedures.

FDA #
K193248
Product Code
KPS
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