IWS · Shield, Eye, Radiological
Radiology · 21 CFR 892.6500 · Class 1
Overview
| Product Code | IWS |
|---|---|
| Device Name | Shield, Eye, Radiological |
| Regulation | 21 CFR 892.6500 |
| Device Class | Class 1 |
| Review Panel | Radiology |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K945515 | COATED TUNGSTEN EYESHIELD | Medtec, Inc. | Jun 19, 1995 | SESE |
| K940119 | ROYAL MARSDEN GOLD GRAIN GUN | Best Industries | Dec 30, 1994 | SESE |
| K943011 | TUNGSTEN EYESHIELD | Medtec, Inc. | Dec 23, 1994 | SESE |
| K934459 | MED-GENESIS PATIENT LASER EYE SHIELD | Med-Genesis, Inc. | Feb 22, 1994 | SESE |
| K934362 | NUCLEAR ASSOCIATES GLASSERS | Victoreen, Inc. | Nov 12, 1993 | SESE |
| K920540 | RADIOLOGICAL PROTECTIVE EYE SHIELD | Burkhart Roentgen Intl., Inc. | May 28, 1992 | SESE |
Top Applicants
- Medtec, Inc. — 2 clearances
- Best Industries — 1 clearance
- Burkhart Roentgen Intl., Inc. — 1 clearance
- Med-Genesis, Inc. — 1 clearance
- Victoreen, Inc. — 1 clearance
