| Device |
radiological computer assisted detection/diagnosis software for fracture |
| Definition |
A radiological computer assisted detection and diagnostic software for suspected fracture is an image processing device intended to aid in the detection, localization, and/or characterization of fracture on acquired medical images (e.g. radiography, MR, CT). The device detects, identifies and/or characterizes fracture based on features or information extracted from images, and may provide information about the presence, location, and/or characteristics of the fracture to the user. Primary diagnostic and patient management decisions are made by the clinical user. |
| Physical State |
Software device that receives radiological images as an input and provides a concurrent read for presence or absence of fracture (detection and diagnosis) as an output |
| Technical Method |
Analyzes radiological images using machine learning algorithms to detect and diagnose fracture. |
| Target Area |
Radiological images of anatomical sites that main contain fracture. |
| Regulation Medical Specialty |
Radiology |
| Review Panel |
Radiology |
|---|
| Product Code | QBS |
|---|
| Premarket Review |
Office of Radiological Health
(OHT8)
Radiological Imaging Devices and Electronic Products
(DHT8B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
892.2090
|
|---|
| 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 |
