C-Arm Fluoroscopic X-Ray System

RCC · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.1650

Classification

FDA Product Code: RCC
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 892.1650
Review panel: RA
Medical specialty: Radiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown