C-arm Fluoroscopic X-ray System

Product Code: RCC

Radiology Medical Diagnostic X-Ray Equipment

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.

Applicable Standards: Diagnostic X-ray Systems And Their Major Components. [1020.30] Radiographic Equipment. [1020.31] Fluoroscopic Equipment. [1020.32] Computed Tomography (CT) Equipment. [1020.33]

Code of Federal Regulations: 892.1650


Radiation TypeIonizing
Radition SafetyNone
Annual ReportsNo

Products Classified as RCC

5429C-arm Fluoroscopic X-ray SystemImage-intensified Fluoroscopic X-ray System.

Total Product Life Cycle (TPLC) Devices

5429C-arm Fluoroscopic X-ray SystemImage-intensified Fluoroscopic X-ray System.

Maude Adverse Events

2018-02-05

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