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Found 7 results
510(k) Data Aggregation
K Number
K110856Device Name
RALCO
Manufacturer
RALCO S.R.L.
Date Cleared
2011-08-10
(135 days)
Product Code
IZX
Regulation Number
892.1610Why did this record match?
Product Code :
IZX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
R104/A, R108 and R108 F Manual X-Ray Collimators are intended for use in diagnostic radiographic/fluoroscopic applications.
Device Description
These are square-field single- or, optionally, multi-layer x-ray collimators. They are lightweight and compact, suited for installation on mobile of fired x-ray equipment. In the standard single- layer version, the x-ray field is defined by two pairs of shutters and a conc at the xray beam window. In the version mounting RO 334, he x-ray field is defined by six pairs of shutters, two of which are leadlined. The six pairs of shutters move perpendicularly within the x-ray field. Four pairs of shutters are in bronze: two are located near the focus and two are leated near the entrance window. Two leaded shutters are located near the exit window of the x-ray beam from the collimator and serve to accurately define the x-ray field edges. Shutter movements are manual and controlled by two knobs on the collimator from panel. The square-field X-ray beam Limiting Device is designed for installation on rotating or fixed anode Xray tubes (mounting RO 334) (EN 60601-1-3 par 29.202.3); manual controls provide for the adjustment of the X-ray field dimension to the size of the image receptor or to that of the anatomical area of interest. Adjustment to the area under investigation is possible by using the knobs on the front panel. Direct visualisation of the x-ray field is provided by a light beam which corresponds to the x-ray bean, within a tolerance of two percent of the selected FFD (SID) value. The light-field centre is provided by the intersection of two perpendicular lines silk-screened into the Lexan window and projected on the light field by the light beam. To activate the light field, press the area marked with the light symbol on the front of the device. The light will switch on for 30 seconds and an electronic timer will switch the lamp OFF automatically.
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K Number
K101036Device Name
SHIMADZU COLLIMATOR R-20J
Manufacturer
SHIMADZU CORP.
Date Cleared
2010-08-26
(134 days)
Product Code
IZX
Regulation Number
892.1610Why did this record match?
Product Code :
IZX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended to be used in radiology.
This collimator is to be used in conjunction with an x-ray generator and x-ray tube to limit the area of radiation that is emitted to a confined field of view. This limits the potential for radiation to the general population in the exam area.
This device is for diagnostic use.
Device Description
This collimator is to be used in conjunction with an x-ray generator and x-ray tube to limit the area of radiation that is emitted to a confined field of view.
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K Number
K042840Device Name
SHIMADZU COLLIMATOR R-20J
Manufacturer
SHIMADZU CORP.
Date Cleared
2004-12-03
(50 days)
Product Code
IZX
Regulation Number
892.1610Why did this record match?
Product Code :
IZX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This collimator is to be used in conjunction with an x-ray generator and x-ray tube to limit the area of radiation that is emitted to a confined field of view. This limits the potential for radiation to the general population in the exam area.
This device is intended to be used in the radiology.
This device is operated and used by Physicians and X-ray technologist.
The object of this device is total patient populations.
As mentioned at "Intended Use" in this clearance letter, the intended use of the R-20J is the same as that of predicate beam limiting device R-30H (K031771). Consequently, the indications for use of the R-20J are also the same as that of the beam limiting device R-30H (K031771) and there are no additional indications.
Device Description
Not Found
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K Number
K031771Device Name
SHIMADZU COLLIMATOR R-30H
Manufacturer
SHIMADZU CORP.
Date Cleared
2003-08-21
(73 days)
Product Code
IZX
Regulation Number
892.1610Why did this record match?
Product Code :
IZX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This collimator is to be used in conjunction with an x-ray generator and x-ray tube to limit the area of radiation that is emitted to a confined field of view. This limits the potential for radiation to the general population in the exam area.
Device Description
Not Found
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K Number
K981267Device Name
FACTS MONOBLOCK
Manufacturer
DYNARAD CORP.
Date Cleared
1998-05-06
(29 days)
Product Code
IZX, ITY, IZO
Regulation Number
892.1610Why did this record match?
Product Code :
IZX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
General Purpose Fluoroscope Applications
Device Description
Not Found
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K Number
K974240Device Name
LIGHTLINE-M
Manufacturer
WUESTEC MEDICAL, INC.
Date Cleared
1997-12-22
(40 days)
Product Code
IZX
Regulation Number
892.1610Why did this record match?
Product Code :
IZX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LightLine-M is intended for use in general purpose diagnostic radiography to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray bean.
Device Description
Not Found
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K Number
K972966Device Name
AXT 150M MANUAL COLLIMATOR (AXT 150M)
Manufacturer
APPLIED X-RAY TECHNOLOGIES, INC.
Date Cleared
1997-08-21
(10 days)
Product Code
IZX
Regulation Number
892.1610Why did this record match?
Product Code :
IZX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AXT 150M and/or its variations is intended to be used by or under the authority of a licensed MD or RT. The AXT 150M and/or its variations is accessories to control the x-ray beam for use on a diagnostic Imaging equipment. The intended market will consist of Original Equipment Manufacturers (OEM), as designed to be adapted to various x-ray systems.
Device Description
AXT 150M Manual Collimator
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