21 CFR 892.1740 — System, X-Ray, Tomographic
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1740
Identification
A tomographic x-ray system is an x-ray device intended to be used to produce radiologic images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. 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 |
|---|---|---|---|---|
| IZF | System, X-Ray, Tomographic | 2 | 42 | 3rd Party |