Screen, Intensifying, Radiographic
Radiology · 21 CFR 892.1960
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
4 recall events for this product code
- General Electric Med SystemsTerminatedJul 20, 2004
GE Single 15 inch TV Monitor Suspension with Rail, Model 46-240485P1, Catalog number B0256EH
The ball joint that attaches the single monitor platform to the system boom could fail causing the monitor to fall.
Z-0850-04 · View FDA record ↗ - General Electric Med SystemsTerminatedJul 20, 2004
GE Single 15 inch TV Monitor Suspension for XT Bridge, Model 46-240485P2, Catalog Number B2056HA
The ball joint that attaches the single monitor platform to the system boom could fail causing the monitor to fall.
Z-0851-04 · View FDA record ↗ - General Electric Med SystemsTerminatedJul 20, 2004
GE Single 20 inch TV Monitor Suspension with Rail, Model 46-240485P5, Catalog Number B2056EC
The ball joint that attaches the single monitor platform to the system boom could fail causing the monitor to fall.
Z-0852-04 · View FDA record ↗ - General Electric Med SystemsTerminatedJul 20, 2004
GE Single 20 inch TV Monitor Suspension for XT Bridge, Model 46-240485P6, Catalog Number B2056EG
The ball joint that attaches the single monitor platform to the system boom could fail causing the monitor to fall.
Z-0853-04 · View FDA record ↗
Registered firms
9 firms currently registered for this product code
Carestream Dental Llc
Atlanta, GA, US
3d Dental Desings And Development
Shaker Heights, OH, US
Kiran Medical Systems A Div Of Trivitron Healthcare Pvt. Ltd
Navi Mumbai Maharashtra, IN
Cargus Int'l, Inc.
CONGERS, NY, US
Fujifilm Healthcare Manufacturing Corporation Minamiashigara Takematsu Office
MINAMIASHIGARA-SHI Kanagawa, JP
Carestream Health, Inc
Rochester, NY, US
Dimedi.co.ltd
Wonju Gangwon, KR
Fujifilm Corporation
ASHIGARAKAMI-GUN Kanagawa, JP
Wolf X-ray Corp
Battleboro, NC, US
510(k) clearances
35 clearances for this product code
- Sterling Diagnostic Imaging, Inc.Dec 22, 1997
K974423 · ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL
- Konica Medical Corp.Oct 8, 1997
K963913 · MD100 & MM150
- Jpi Healthcare Co, Ltd.Feb 2, 1996
K954161 · JPI INTENSIFYING SCREEN
- Fujifilm Medical System U.S.A., Inc.Aug 22, 1994
K943821 · KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPEC
- Fujifilm Medical System U.S.A., Inc.Aug 22, 1994
K943822 · FUJI UM MAMMO SERIES INTENSIFY SCREENS:
- Fujifilm Medical System U.S.A., Inc.Aug 22, 1994
K943823 · FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12
- Fujifilm Medical System U.S.A., Inc.Aug 17, 1994
K942235 · KYOKKO GREEN SERIES INTENSIFYING SCREENS
- Fujifilm Medical System U.S.A., Inc.Aug 17, 1994
K943425 · FUJI HG-M INTENSIFYING SCREEN