EAK · Screen, Leaded, Operator Radiation Protector
Radiology · 21 CFR 892.6500 · Class 1
Overview
| Product Code | EAK |
|---|---|
| Device Name | Screen, Leaded, Operator Radiation Protector |
| 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 (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K952233 | CLEAR-PB LEAD PLASTIC OVERHEAD BARRIER 56-628 | Victoreen, Inc. | Jun 16, 1995 | SESE |
| K944445 | ED CORP RADIATION SCREEN | Med Corp. | May 11, 1995 | SESE |
| K944772 | MULTIPLE ED1600 SERIES RADIATION SHIELDS | Image Diagnostics, Inc. | Oct 20, 1994 | SESE |
| K896949 | MOBILE X-RAY PERSONNEL PROTECTIVE SCREENS | Innovative Products Mfg. | Feb 16, 1990 | SESE |
| K861019 | CEILING MOUNT COUNTERPOISED SECON RADIATION SHIELD | Phase One Disign Co. | Apr 2, 1986 | SESE |
| K850816 | LEAD PLASTIC VIEWING PANELS | Victoreen, Inc. | Apr 10, 1985 | SESE |
| K850814 | MODULAR X-RAY BARRIERS | Victoreen, Inc. | Apr 10, 1985 | SESE |
Top Applicants
- Victoreen, Inc. — 3 clearances
- Image Diagnostics, Inc. — 1 clearance
- Innovative Products Mfg. — 1 clearance
- Med Corp. — 1 clearance
- Phase One Disign Co. — 1 clearance
