| Device |
x-ray angiographic imaging based coronary vascular simulation software device |
| Regulation Description |
Angiographic x-ray system. |
| Definition |
X-ray angiographic imaging based coronary vascular simulation software device is a prescription device that provides an image analysis tool to assess blood flow in the coronary vascular system using X-ray angiographic imaging data. X-ray angiographic imaging based coronary vascular simulation software device solves algorithms and yields simulation-based metrics for certain cardiology applications. X-ray angiographic imaging based coronary vascular simulation software device cannot be used alone for clinical decision making and clinical management, and is a tool intended to generate results for use and review by a qualified clinician. |
| Physical State |
Software device that receives X-ray angiographic image data as an input and provides the user with an image analysis tool that cannot be used alone for clinical decision making and clinical management. |
| Technical Method |
Analyzes X-ray angiographic data using fluid dynamic simulation algorithms to yield simulation-based metrics for certain cardiology applications. |
| Target Area |
X-ray angiographic images of the cardiac vasculature. |
| Regulation Medical Specialty |
Radiology |
| Review Panel |
Radiology |
|---|
| Product Code | QHA |
|---|
| Premarket Review |
Office of Radiological Health
(OHT8)
Radiological Imaging Devices and Electronic Products
(DHT8B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
892.1600
|
|---|
| 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 |
