SENOGRAPHE 600T AND 600TS SENIX HF
Device Facts
| Record ID | K881882 |
|---|---|
| Device Name | SENOGRAPHE 600T AND 600TS SENIX HF |
| Applicant | General Electric Co. |
| Product Code | IZH · Radiology |
| Decision Date | May 25, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1710 |
| Device Class | Class 2 |
Regulatory Classification
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.