21 CFR 892.1710 — System, X-Ray, Mammographic
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1710
Identification
A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. 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 |
|---|---|---|---|---|
| IZH | System, X-Ray, Mammographic | 2 | 176 | 3rd Party |
| POY | Post Breast Biopsy Hemostatic Breast Compression Device | 2 | 1 |
