| Device |
image acquisition and/or optimization guided by artificial intelligence |
| Definition |
A radiological acquisition and/or optimization guidance system is a device that is intended to aid in the acquisition and/or optimization of images and/or diagnostic signals. The device interfaces with the acquisition system, analyzes its output, and provides guidance and/or feedback to the operator for improving image and/or signal quality. |
| Physical State |
The subject software would utilize images acquired using an imaging system. The software can be installed on an existing imaging system, or can be operated on a computer that is connected to the imaging system. |
| Technical Method |
The device's algorithm would be based on the analysis of images and/or diagnostic data. The underlying algorithms used for providing guidance to the users may be based on deep learning methods, trained on images obtained by trained operators. |
| Target Area |
Human body |
| Regulation Medical Specialty |
Radiology |
| Review Panel |
Radiology |
|---|
| Product Code | QJU |
|---|
| Premarket Review |
Office of Radiological Health
(OHT8)
Division of Radiological Imaging and Radiation Therapy Devices
(DHT8C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
892.2100
|
|---|
| 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 |
