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U.S. Department of Health and Human Services

Product Classification

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Device tomographic imager combining emission computed tomography with nuclear magnetic resonance
Regulation Description Emission computed tomography system.
Definition Imager that generates both both magnetic resonance (mr) and positron emission tomography (pet) images and provides registration and fusion of these images. Pet and mr images can be acquired either simultaneously or sequentially. Anatomical mr images are used for pet attenuation correction.
Physical State The combined imager includes hardware and software for acquisition and reconstruction of both PET and MR images. Software for image fusion/registration is also included
Technical Method MRI creates images based on the spatial distribution of hydrogen nuclei; PET creates images based on the biodistribution of a radiopharmaceutical. Radiation from the MRI is non-ionizing radiofrequency radiation; radiation from the PET radiopharmaceutical is ionizing.
Target Area whole body
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeOUO
Premarket Review Office of Radiological Health (OHT8)
Division of Radiological Imaging and Radiation Therapy Devices (DHT8C)
Submission Type 510(k)
Regulation Number 892.1200
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible