IWQ · Curtain, Protective, Radiographic
Radiology · 21 CFR 892.6500 · Class 1
Overview
| Product Code | IWQ |
|---|---|
| Device Name | Curtain, Protective, Radiographic |
| 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 |
|---|---|---|---|---|
| K945238 | MAVIG LOWER BODY PROTECTION SYSTEMS, ASSEMBLY MODELS 6265, 6266, 6267, 6268, 6269/0, 629/1, AND 6269/2 | F. Walter Hanel GmbH | Dec 15, 1994 | SESE |
| K923099 | X-RAY DRAPES | Hydro-Med Products, Inc. | Oct 15, 1992 | SESE |
| K873038 | TECHTON PROTECTIVE PAD | Techton, Inc. | Apr 3, 1989 | SESE |
Top Applicants
- Techton, Inc. — 1 clearance
- Hydro-Med Products, Inc. — 1 clearance
- F. Walter Hanel GmbH — 1 clearance
