PLANMED SOPHIE MAMMOGRAPHIC X-RAY UNIT
Device Facts
| Record ID | K951883 |
|---|---|
| Device Name | PLANMED SOPHIE MAMMOGRAPHIC X-RAY UNIT |
| Applicant | Planmed OY |
| Product Code | IZH · Radiology |
| Decision Date | May 24, 1995 |
| 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.
