RCC — C-Arm Fluoroscopic X-Ray System Class II
FDA product code RCC covers "C-Arm Fluoroscopic X-Ray System", a Class II medical device regulated under 21 CFR 892.1650. Submissions are reviewed by the Radiology panel.
Classification Details
- Product Code
- RCC
- Device Class
- Class II
- Regulation Number
- 892.1650
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
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.