Product code RCC

Device name

C-Arm Fluoroscopic X-Ray System

Medical specialty

Radiology

Device class

2

Regulation number

892.1650

Review panel

RA

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset