Device |
c-arm fluoroscopic x-ray system |
Regulation Description |
Image-intensified fluoroscopic x-ray system. |
Definition |
Fluoroscopic x-ray system in which the image receptor and x-ray tube housing assembly are connected or coordinated to maintain a spatial relationship. Such a system allows a change in the direction of the beam axis with respect to the patient without moving the patient. |
Regulation Medical Specialty |
Radiology |
Review Panel |
Radiology |
Product Code | RCC |
Premarket Review |
Office of Radiological Health
(OHT8)
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
|
Accredited Persons
|