FDA Radiology AI Devices

The DigitMI 930 is a PET/CT imaging system that combines positron emission tomography and computed tomography to produce detailed images of metabolic and physiological functions in the body. It helps clinicians detect, localize, evaluate, diagnose, and monitor a wide range of conditions including cancer, cardiovascular disease, and neurological disorders by providing precise anatomical and functional imaging.

The Aurora system is a hybrid medical imaging device combining nuclear medicine (SPECT) and computed tomography (CT) technologies to help healthcare professionals detect, diagnose, and monitor diseases such as cardiovascular disorders, neurological conditions, and cancer. It enhances images using advanced acquisition, gating, and software features, improving evaluation and patient care across a variety of clinical applications.

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.

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.