Device |
cross-sectional mammographic xray system |
Definition |
Diagnostic breast imaging. Imaging of the breast by cross-sectional x-ray imaging for diagnostic purposes. |
Physical State |
medical diagnostic x-ray imaging system |
Technical Method |
x-ray imaging |
Target Area |
breast |
Review Panel |
Radiology |
Product Code | OLQ |
Premarket Review |
Office of Radiological Health
(OHT8)
Division of Radiological Imaging and Radiation Therapy Devices
(DHT8C)
|
Submission Type |
PMA
|
Device Class |
3
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |