21 CFR 892.1720 — System, X-Ray, Mobile

Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1720

Identification

A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. 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
IZLSystem, X-Ray, Mobile22343rd Party
Innolitics

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