21 CFR 892.1750 — System, X-Ray, Tomography, Computed
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1750
Identification
A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. 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 |
|---|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 2 | 817 | 3rd Party |
| OAS | X-Ray, Tomography, Computed, Dental | 2 | 131 | |
| SFV | X-Ray, Computed Tomography, Cone-Beam | 2 | 1 |
