Collimator, Manual, Radiographic
Radiology · 21 CFR 892.1610
Recent MDR events
5 adverse event reports on file
- SUMMIT SWIVEL COLLIMATORJul 17, 2014MalfunctionSummit Industries, Llc1450503-2014-00001
- SUMMIT SWIVEL COLLIMATORJun 26, 2007MalfunctionSummit Industries, Inc.1450503-2007-00002
- NM MILLENNIUM MPR COLLIMATORDec 30, 2004InjuryGe Medical Systems, F.i. Haifa9613299-2004-00010
- EUREKA LINEAR IIIPMay 21, 1998OtherProgeny, Inc.1423380-1998-00001
- PROGENCY, INCApr 23, 1998MalfunctionProgeny, Inc.MW1013630
Event type breakdown
Most-reported manufacturers
Recalls
4 recall events for this product code
- Shimadzu Medical SystemsTerminatedNov 8, 2012
R-20J , Diagnostic X-Ray Beam-Limiting Device.
Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.
Z-0261-2013 · View FDA record ↗ - Summit Industries Inc.TerminatedAug 29, 2007
LX125 Swivel Collimator, Model D800; Manual Radiographic Collimator; Summit Industries, Inc., Chicago, Illinois
The D800 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table.
Z-1216-2007 · View FDA record ↗ - Summit Industries Inc.TerminatedAug 29, 2007
LX125V Swivel Collimator, Model E600; Manual Radiographic Collimator; Summit Industries, Inc., Chicago, Illinois
The E600 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table.
Z-1217-2007 · View FDA record ↗ - Summit Industries Inc.TerminatedAug 29, 2007
PCS125 Swivel Collimator, Model F100; Manual Radiographic Collimator; Summit Industries, Inc., Chicago, Illinois
The F100 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table.
Z-1218-2007 · View FDA record ↗
Registered firms
16 firms currently registered for this product code
Huestis Machine Corp.
Bristol, RI, US
Shimadzu Corporation Medical Systems Division
KYOTO, JP
Philips Medical Systems Nederland B.v.
BEST Noord-Brabant, NL
Del Medical, Inc.
Bloomingdale, IL, US
Summit Industries, Llc
Niles, IL, US
Accogent Pausch
Tinton Falls, NJ, US
Philips Medical Systems Nederland B.v.
BEST Noord-Brabant, NL
Iray Imaging Technology (haining) Limited
Haining Zhejiang, CN
Fairy Medical Electrics(jiaxing)co.,ltd
Jiaxing Zhejiang, CN
Dentsply Llc
York, PA, US
Ralco S.r.l.
Biassono Monza e Brianza, IT
Drgem Corporation (gimcheon Factory)
Gimcheon-si Gyeongbuk, KR
Drgem Corporation
Gwangmyeong-si Gyeongbuk, KR
Collimare, Llc
Golden, CO, US
510(k) clearances
17 clearances for this product code
- Ralco S.R.L.Aug 10, 2011
K110856 · RALCO
- Shimadzu Corp.Aug 26, 2010
K101036 · SHIMADZU COLLIMATOR R-20J
- Shimadzu Corp.Dec 3, 2004
K042840 · SHIMADZU COLLIMATOR R-20J
- Shimadzu Corp.Aug 21, 2003
K031771 · SHIMADZU COLLIMATOR R-30H
- Dynarad Corp.May 6, 1998
K981267 · FACTS MONOBLOCK
- Wuestec Medical, Inc.Dec 22, 1997
K974240 · LIGHTLINE-M
- Applied X-Ray Technologies, Inc.Aug 21, 1997
K972966 · AXT 150M MANUAL COLLIMATOR (AXT 150M)
- Rinn Corp.Jul 26, 1993
K932134 · RINN UNIVERSAL COLLIMATOR