PROGNOST ES, MODEL 0302 0000
Device Facts
| Record ID | K011290 |
|---|---|
| Device Name | PROGNOST ES, MODEL 0302 0000 |
| Applicant | Xmar Corp. |
| Product Code | IZF · Radiology |
| Decision Date | May 30, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1740 |
| Device Class | Class 2 |
Regulatory Classification
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.
