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Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.1200
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 892.1200 Emission computed tomography system

§ 892.1200 Emission computed tomography system.

(a) Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

(b) Classification. Class II.

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.1200
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 892.1200 Emission computed tomography system

§ 892.1200 Emission computed tomography system.

(a) Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

(b) Classification. Class II.