AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM
Device Facts
| Record ID | K010721 |
|---|---|
| Device Name | AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM |
| Applicant | Siemens Medical Corp. |
| Product Code | IZI · Radiology |
| Decision Date | Mar 30, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1600 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
