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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?
Applicant Name (Manufacturer) :
RALCO S.R.L.
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
K091517Device Name
RALCO, MODEL R225 ACS
Manufacturer
RALCO S.R.L.
Date Cleared
2009-07-14
(53 days)
Product Code
IZW
Regulation Number
892.1610Why did this record match?
Applicant Name (Manufacturer) :
RALCO S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Model R225 ACS Automatic X-RAY Collimator is intended for use in diagnostic radiographic/fluoroscopic applications.
Device Description
This x-ray collimator Multilayer, square-field, automatic collimation system. Stepper motors control the movements of shutters and the additional filter. There is a mounting plane at 80 mm (3.15") from the focus. A microprocessor circuit controls the stepper motors and provides the stepless adjustment of the square field dimensions at variable FFD (SID). The field dimensions may be decreased and increased to the set value by two knobs placed on the collimator front panel.
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K Number
K083029Device Name
MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR
Manufacturer
RALCO S.R.L.
Date Cleared
2008-12-05
(56 days)
Product Code
IZW
Regulation Number
892.1610Why did this record match?
Applicant Name (Manufacturer) :
RALCO S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Model R605DASM Automatic X-RAY Collimator is intended for use in diagnostic radiographic/fluoroscopic applications.
Device Description
This device is a compact radiological automatic collimating system for round and elliptic fields designed to operate with a mobile "C" arm Image Intensifier cquipment. The round and elliptical fields are defined as follows: The round field by 8 lead shutters located near the exit window and a brass cone near the x-ray focus; the elliptical field by the round field and two pairs of lead rectangular shutters located near the collimator entrane window. Round and elliptical field shutters are controlled by 5 stepping motors. The circlinator features a microprocessor circuit built into the collimator to control the 5 stepping-motornia external signal source with CanBus protocol. The circuits return a CanBus protocol signal to indicate correct motor positioning. The two pairs of lead rectangular shutters move isignify and both rotate ± 360° ..
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K Number
K072780Device Name
MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR
Manufacturer
RALCO S.R.L.
Date Cleared
2007-11-26
(59 days)
Product Code
IZW
Regulation Number
892.1610Why did this record match?
Applicant Name (Manufacturer) :
RALCO S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Model R302DACS/A Automatic X-RAY Collimator is intended for use in diagnostic radiographic/fluoroscopic applications.
Device Description
Model R302DACS/A Automatic X-RAY Collimator is an Automatic X-ray beam-limiting system with a multilayer square field collimator. Stepper motors drive shutter movements as well as additional filters and the round field if these two features are mounted. A microprocessor circuit controls the stepper motors and provides the stepless adjustment of the square field dimensions at variable FFD (SID). The two stepper motors that provide shutter control may also be manually adjusted by the two knobs or by the pushbuttons located on the front panel. Two boards built into the collimator allow direct control of the system via CAN-Bus protocol.
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K Number
K030487Device Name
R 72
Manufacturer
RALCO S.R.L.
Date Cleared
2003-08-01
(168 days)
Product Code
KPW
Regulation Number
892.1610Why did this record match?
Applicant Name (Manufacturer) :
RALCO S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Model R72 is intended to be used as an X-Ray beam limitation device on portable and mobile diagnostic X-Ray units.
Device Description
R72 X-Ray Collimator: External cover in abs plastic Single-layer, square field radiological collimator. Focus/mounting flange plane distance is 70mm. The X-ray field size is limited by two pairs of lead shutters controlled by two knobs located on the sides of the collimator, a lead cone situated near the x-ray anode reduces the off-focus radiation. Its light weight and compact size allow easy positioning and make it ideal for portable units. A table on the front panel allows the operator to read field dimensions set with the knobs.
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