21 CFR 892.1660 — System, X-Ray, Fluoroscopic, Non-Image-Intensified

Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1660

Identification

A non-image-intensified fluoroscopic x-ray system is a device intended to be used to visualize anatomical structures by using a fluorescent screen to convert a pattern of x-radiation into a visible image. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
JABSystem, X-Ray, Fluoroscopic, Non-Image-Intensified223rd Party
Innolitics

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