Device |
system, radiation therapy, radionuclide |
Regulation Description |
Radionuclide radiation therapy system. |
Regulation Medical Specialty |
Radiology |
Review Panel |
Radiology |
Product Code | IWB |
Premarket Review |
Office of Radiological Health
(OHT8)
Radiological Imaging and Radiation Therapy Devices
(DHT8C)
|
Submission Type |
510(k)
|
Regulation Number |
892.5750
|
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 |
|
|