LASER ALIGNMENT TOOL
Device Facts
| Record ID | K943381 |
|---|---|
| Device Name | LASER ALIGNMENT TOOL |
| Applicant | Philips Medical Systems North America, Inc. |
| Product Code | IWE · Radiology |
| Decision Date | Aug 9, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.5780 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A light beam patient position indicator is a device that projects a beam of light (incoherent light or laser) to determine the alignment of the patient with a radiation beam. The beam of light is intended to be used during radiologic procedures to ensure proper positioning of the patient and to monitor alignment of the radiation beam with the patient's anatomy.