LEKSELL STEREOTACTIC SYSTEM
Device Facts
| Record ID | K802140 |
|---|---|
| Device Name | LEKSELL STEREOTACTIC SYSTEM |
| Applicant | Downs Surgical , Ltd. |
| Product Code | IWY · Radiology |
| Decision Date | Feb 5, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1920 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A radiographic head holder is a device intended to position the patient's head during a radiographic procedure.