| 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 Code | OUO |
|---|
| Premarket Review |
Office of Radiological Health
(OHT8)
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
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Recognized Consensus Standards
|
| Third Party Review |
Not Third Party Eligible |
