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 Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JAB | System, X-Ray, Fluoroscopic, Non-Image-Intensified | 2 | 2 | 3rd Party |