| Device |
radiological machine learning based quantitative imaging software with change control plan |
| Definition |
A radiological machine learning quantitative imaging software with predetermined change control plan is a software-only device which employs machine learning algorithms on radiological images to provide quantitative imaging outputs. The device includes functions to support outputs such as view selection, segmentation and landmarking. The design specifications include planned modifications that may be made to the device consistent with an established predetermined change control plan. |
| Physical State |
Software device. |
| Technical Method |
Software implementing artificial intelligence including adaptive machine learning algorithms trained with clinical and/or artificial data. The training data typically impacts generalizability of the device. The device involves a specific plan for how the machine learning algorithms could be modified in the future. |
| Target Area |
The device operates on radiological images of the human body. |
| Regulation Medical Specialty |
Radiology |
| Review Panel |
Radiology |
|---|
| Product Code | QVD |
|---|
| Premarket Review |
Office of Radiological Health
(OHT8)
Radiological Imaging Devices and Electronic Products
(DHT8B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
892.2055
|
|---|
| 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 |
