Product code OUO

Device name
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Medical specialty
Radiology
Device class
2
Regulation number
892.1200
Review panel
RA
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
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.
Source
FDA openFDA device classification dataset