| Device |
adjunctive epicardial vascular physiologic status indicator |
| Regulation Description |
Adjunctive cardiovascular status indicator. |
| Definition |
The adjunctive epicardial vascular physiologic status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting the possible presence of functionally significant coronary artery disease to suggest the need for further testing. This device is intended for adjunctive use with other clinical workup or patient information and is not intended to quantify the degree to which epicardial disease is limiting flow through a vessel nor is it intended to independently direct therapy. |
| Physical State |
Software/Firmware |
| Technical Method |
The device analyzes patient data (such as computed tomography images) and provides an output that indicates likelihood of the presence of functionally significant coronary artery disease. |
| Target Area |
Various |
| Regulation Medical Specialty |
Cardiovascular |
| Review Panel |
Cardiovascular |
|---|
| Product Code | QXZ |
|---|
| Premarket Review |
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
(DHT2A)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
(DHT2A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
870.2200
|
|---|
| 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 |
