| Device |
radiological software device to predict future breast cancer risk |
| Definition |
A radiological software device to predict future breast cancer risk is a device that analyzes radiological images generated by breast imaging modalities and/or inputs derived from radiological images to provide qualified healthcare professionals with a prediction of the risk of future (incident) breast cancer. This device produces a numeric probability and/or risk category indicative of the patient’s future breast cancer risk from the time the analyzed images were acquired. This device is not intended to diagnose, detect, or inform the treatment of cancer. The output of this device is not intended to guide interpretation of imaging exams. |
| Physical State |
The device is software only. |
| Technical Method |
The device analyzes radiological images using machine learning, artificial intelligence or other image analysis algorithms to provide qualified healthcare professionals with a prediction of the risk of future breast cancer. |
| Target Area |
Breast |
| Regulation Medical Specialty |
Radiology |
| Review Panel |
Radiology |
|---|
| Product Code | SEZ |
|---|
| Premarket Review |
Office of Radiological Health
(OHT8)
Radiological Imaging and Radiation Therapy Devices
(DHT8C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
892.8500
|
|---|
| Device Class |
2
|
| 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 |
