| Device |
solid state fluoroscopic x-ray imager |
| Regulation Description |
Image-intensified fluoroscopic x-ray system. |
| Definition |
To instantaneously convert an x-ray pattern from a fluoroscopic x-ray system into a corresponding light image of higher energy density. |
| Physical State |
Typically contained within a plastic or metal housing and typically flat and rectangular. May be connected to other components of a fluoroscopic x-ray system through wired or wireless means. |
| Technical Method |
Uses a indirect-conversion (x-ray scintillator based) or direct-conversion (x-ray photoconductor based) methods to convert fluoroscopic x-ray patterns into electric signals. |
| Target Area |
May be used to image any part of the body which is/may be in motion. |
| Regulation Medical Specialty |
Radiology |
| Review Panel |
Radiology |
|---|
| Product Code | QHY |
|---|
| Premarket Review |
Office of Radiological Health
(OHT8)
Division of Radiological Imaging Devices and Electronic Products
(DHT8B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
892.1650
|
|---|
| 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 |
