Screen, Leaded, Operator Radiation Protector
Radiology · 21 CFR 892.6500
Recent MDR events
10 adverse event reports on file
- RAYSHIELDDec 3, 2009MalfunctionAadco MedicalMW5013821
- *Mar 29, 2006MalfunctionHandelMW1038363
- KENEXMar 8, 2006MalfunctionKenex (electro-medical) Ltd.692325
- GE - L/FAug 6, 2004*538567
- *Jul 28, 2003MalfunctionNelco, Inc476171
- KENNEX RADIATION SHIELDSep 19, 1996MalfunctionSiemens Medical Systems, Inc.MW1009953
- CEILING MOUNTED LEAD SHIELD/HOLDERJun 20, 1996MalfunctionToshiba America Medical Systems, Inc.MW1009331
- CEILING SUSPENDED RADIATION SHIELD SUPPORTMay 19, 1994Philips Medical SystemsMW4000396
- BURKHARDT-ROENTGEN RAD SHIELDMay 18, 1994InjuryBurkhart-roentgen2126677-1994-00009
- 2000 SYSTEMJan 10, 1994MalfunctionBurkhart Roentgen, Inc.2020563-1993-00016
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
21 firms currently registered for this product code
Steris Corporation
MONTGOMERY, AL, US
Egg Medical, Inc.
Roseville, MN, US
Salus Scientific Corp
Charleston, SC, US
Jiangsu Jumao X-care Medical Equipment Co., Ltd
Danyang Jiangsu, CN
Aadco Medical, Inc.
RANDOLPH, VT, US
Zhengzhou Henghao Optical Technology Co. Ltd.
Zhengzhou Henan, CN
Trans Radial Solutions
Roebuck, SC, US
Kenex (electro-medical) Ltd.
HARLOW Essex, GB
Ultraray Group Inc.
Oakville Ontario, CA
Msline Eng Co Ltd
Icheon-si Gyeonggi, KR
Ft Industries, Inc
Bessemer, AL, US
Phillips Safety Products, Inc.
Middlesex, NJ, US
Ecls
Saint Louis, MO, US
Image Diagnostics, Inc.
Fitchburg, MA, US
Techno-aide, Inc.
Whites Creek, TN, US
Infab, Llc.
CAMARILLO, CA, US
Burlington Medical, Llc
Newport News, VA, US
Alimed, Llc
DEDHAM, MA, US
Mavig Gmbh
MUNICH Bavaria, DE
Rampart Ic, Inc
Vestavia, AL, US
Rampart Ic, Inc
Birmingham, AL, US
510(k) clearances
7 clearances for this product code
- Victoreen, Inc.Jun 16, 1995
K952233 · CLEAR-PB LEAD PLASTIC OVERHEAD BARRIER 56-628
- Med Corp.May 11, 1995
K944445 · ED CORP RADIATION SCREEN
- Image Diagnostics, Inc.Oct 20, 1994
K944772 · MULTIPLE ED1600 SERIES RADIATION SHIELDS
- Innovative Products Mfg.Feb 16, 1990
K896949 · MOBILE X-RAY PERSONNEL PROTECTIVE SCREENS
- Phase One Disign Co.Apr 2, 1986
K861019 · CEILING MOUNT COUNTERPOISED SECON RADIATION SHIELD
- Victoreen, Inc.Apr 10, 1985
K850814 · MODULAR X-RAY BARRIERS
- Victoreen, Inc.Apr 10, 1985
K850816 · LEAD PLASTIC VIEWING PANELS