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 |