KPY · Shield, Protective, Personnel
Radiology · 21 CFR 892.6500 · Class 1
Overview
| Product Code | KPY |
|---|---|
| Device Name | Shield, Protective, Personnel |
| 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 (20 of 25)
Showing 20 most recent of 25 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K110900 | DISPOSABLE THYROID COLLAR | Bloxr Corporation | Jun 24, 2011 | SESE |
| K962622 | INTRA-ORAL THERMOPLASTIC SHIELD | Medtec, Inc. | Oct 1, 1996 | SESE |
| K954456 | THERMOPLASTIC SHIELD | Medtec, Inc. | Dec 21, 1995 | SESE |
| K954146 | UTK-DTE AUTILARY SHIELD | Mallinckrodt Medical | Dec 6, 1995 | SESE |
| K953610 | AUKULYTE | Aukland Medical Plastics, Inc. | Sep 26, 1995 | SESE |
| K951004 | 2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4) | Kenex , Ltd. | Apr 10, 1995 | SESE |
| K951003 | KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5) | Kenex , Ltd. | Apr 3, 1995 | SESE |
| K940539 | STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM | Standard Imaging, Inc. | Mar 16, 1994 | SESE |
| K934206 | MAVIG ANGIO SHIELD MODELS 6290 & 6272 | F. Walter Hanel GmbH | Oct 7, 1993 | SESE |
| K912378 | DAVIS LEAD APRON/RADIOGRAPHIC VARIOUS CAT. NUMBERS | Davis Lead Aprons, Inc. | Mar 18, 1992 | SESE |
| K912327 | DAVIS LEAD APRON GONADAL SHIELD-VARIOUS CAT. NOS. | Davis Lead Aprons, Inc. | Mar 18, 1992 | SESE |
| K912326 | DAVIS LEAD APRON - VARIOUS CATALOGUE NUMBERS | Davis Lead Aprons, Inc. | Mar 18, 1992 | SESE |
| K900970 | RADIATION PROTECTION GLASSES | Infab Corp. | May 1, 1990 | SESE |
| K896511 | DU PONT XENOLITE(TM) RADIATION PROTECTION APPAREL | E.I. Dupont DE Nemours & Co., Inc. | Dec 22, 1989 | SESE |
| K896289 | RADIATION PROTECTION APRON | Infab Corp. | Dec 14, 1989 | SESE |
| K871502 | PERSONNEL PROTECTIVE SHIELD | Cis-Us, Inc. | May 8, 1987 | SESE |
| K844160 | VENTIBOX | Syncor Intl. Corp. | Dec 17, 1984 | SESE |
| K811677 | KRYPTON CART | Medi-Physics Inc. Dba Nycomed Amersham Imaging | Jul 2, 1981 | SESE |
| K811068 | BYPASS COIL | G.D. Searle and Co. | May 27, 1981 | SESE |
| K810095 | MOTI APRON | Moti Enterprises, Inc. | Feb 12, 1981 | SESE |
Top Applicants
- Davis Lead Aprons, Inc. — 3 clearances
- Infab Corp. — 2 clearances
- Kenex , Ltd. — 2 clearances
- Medtec, Inc. — 2 clearances
- Moti Enterprises, Inc. — 2 clearances
