Device |
optoacoustic imaging system |
Definition |
The device is indicated for imaging the breast using optoacoustic technology for breast cancer diagnosis |
Physical State |
Hardware and software for acquiring, processing, and displaying optoacoustic images. |
Technical Method |
Images are acquired utilizing acoustic emissions caused by optical, pulsed excitation for visualization of the relative amount of laser light absorption by the tissue, depicting tissue oxygenation. |
Target Area |
Breast |
Review Panel |
Radiology |
Product Code | QNK |
Premarket Review |
Office of Radiological Health
(OHT8)
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 |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |