IWX · Barrier, Control Panel, X-Ray, Movable
Radiology · 21 CFR 892.6500 · Class 1
Overview
| Product Code | IWX |
|---|---|
| Device Name | Barrier, Control Panel, X-Ray, Movable |
| 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 (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K881591 | A2J MZ 45 LASER LIGHT FOR POSITIONING | A2j, Inc. | Apr 27, 1988 | SESE |
| K850813 | MOBILE LEAD PLASTIC X-RAY BARRIERS | Victoreen, Inc. | Apr 10, 1985 | SESE |
| K781068 | AUTOMATIC FILM PROCESSORIO M. R80 | Tecnomed, Inc. | Jul 17, 1978 | SESE |
Top Applicants
- Victoreen, Inc. — 1 clearance
- Tecnomed, Inc. — 1 clearance
- A2j, Inc. — 1 clearance
