KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5)
Device Facts
| Record ID | K951003 |
|---|---|
| Device Name | KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5) |
| Applicant | Kenex , Ltd. |
| Product Code | KPY · Radiology |
| Decision Date | Apr 3, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.6500 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation. This generic type of device may include articles of clothing, furniture, and movable or stationary structures.
