SOMATOM DEFINITION EDGE
Device Facts
| Record ID | K120579 |
|---|---|
| Device Name | SOMATOM DEFINITION EDGE |
| Applicant | Siemens Medical Systems, Inc. |
| Product Code | JAK · Radiology |
| Decision Date | May 23, 2012 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1750 |
| Device Class | Class 2 |
Regulatory Classification
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.
