| Device |
radiology software for opportunistic evaluation of low bone mineral density |
| Definition |
This device is software which opportunistically assesses radiological images to estimate bone mineral density (BMD) intended to assist in a healthcare professional's decision to evaluate patients for possible low BMD within a bone health screening program. The software employs an algorithm that estimates BMD using eligible radiological image data obtained for other clinical purposes. |
| Physical State |
Software device that receives radiological image data as an input and identifies patients with possibly low BMD. It cannot be used to rule out low BMD. |
| Technical Method |
Analyzes radiological data using locked image processing algorithm to estimate BMD values. Software may implement artificial intelligence algorithms. The algorithm training data typically impacts device performance. |
| Target Area |
Human-derived radiological imaging products. |
| Regulation Medical Specialty |
Radiology |
| Review Panel |
Radiology |
|---|
| Product Code | SAO |
|---|
| Premarket Review |
Office of Radiological Health
(OHT8)
Radiological Imaging Devices and Electronic Products
(DHT8B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
892.1171
|
|---|
| 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 |
