Device, Beam Limiting, X-ray, Diagnostic
Radiology · 21 CFR 892.1610
Recent MDR events
8 adverse event reports on file
- SUMMIT COLLIMATORJun 17, 2014InjurySummit Industries3929691
- SUMMIT SWIVEL COLLIMATORMay 22, 2007MalfunctionSummit Industries, Inc.1450503-2007-00001
- PEGASYSSep 25, 2003MalfunctionAdac LaboratoriesMW1029682
- LINEAR SERIES COLLIMATORSJan 29, 2001MalfunctionProgeny, Inc.1423380-2001-00001
- ULTRANET COLLIMATORSep 26, 1997MalfunctionGeneral Electric Co.57331-1997-00032
- AUTO COLLIMATORAug 21, 1997MalfunctionPhilips Medical Systems1217116-1997-00027
- EIMAC-VARIANNov 19, 1996OtherElimac Varian (sold To: Fisher/machett)51396
- COLLIMATOROct 24, 1996MalfunctionSiemens Medical Systems, Inc.MW1010148
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
14 firms currently registered for this product code
Philips Medical Systems Dmc Gmbh
HAMBURG, DE
Philips Electronics Ltd
Mississauga Ontario, CA
Fairy Medical Electrics(jiaxing)co.,ltd
Jiaxing Zhejiang, CN
Ralco S.r.l.
Biassono Monza e Brianza, IT
Siemens Shanghai, Medical Equipment Ltd.
SHANGHAI, CN
M-solutions Inc.
Tokyo, JP
Villa Sistemi Medicali S.p.a.
BUCCINASCO Milano, IT
Siemens Healthineers Ag
KEMNATH Bavaria, DE
Sts Corporation
Duluth, GA, US
510(k) clearances
16 clearances for this product code
- Lumos, Inc.Jan 12, 2010
K093596 · LUMOS, MODEL R 72B
- Umi InternationalDec 28, 2006
K062788 · COLLIMATOR, MODEL M-38
- Ralco S.R.L.Aug 1, 2003
K030487 · R 72
- Toshiba Medical SystemsOct 18, 1995
K954310 · BLA-800A
- Ralco S.R.L.May 11, 1995
K946320 · R 302
- Precise OpticsNov 27, 1991
K914184 · P2020-8-0 BEAM-LIMITING DEVICE
- L. Keroack Co.Jan 24, 1991
K904587 · DENSICOMP 250
- Toshiba America Medical Systems, In.CNov 29, 1990
K904044 · TF-63SA