EAJ · Apron, Leaded
Radiology · 21 CFR 892.6500 · Class 1
Overview
| Product Code | EAJ |
|---|---|
| Device Name | Apron, Leaded |
| 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 |
|---|---|---|---|---|
| K931269 | LEAD APRON | Bt Medical Co., Inc. | Jun 2, 1993 | SESE |
| K913621 | RINN PROTECTIVE X-RAY APRON AND PROTECTIVE COLLAR | Rinn Dental Products | Sep 27, 1991 | SESE |
| K870563 | X-RAY APRON | X-Tech, Ltd. | Feb 19, 1987 | SESE |
| K870103 | LEAD APRON CADDY | Orthopedic Systems, Inc. | Jan 21, 1987 | SESE |
| K832602 | THYROID PROTECTIVE COLLAR | E.M. Adams | Sep 29, 1983 | SESE |
| K832601 | LEADED X-RAY APRON | E.M. Adams | Sep 29, 1983 | SESE |
Top Applicants
- E.M. Adams — 2 clearances
- X-Tech, Ltd. — 1 clearance
- Rinn Dental Products — 1 clearance
- Orthopedic Systems, Inc. — 1 clearance
- Bt Medical Co., Inc. — 1 clearance
