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510(k) Data Aggregation
K Number
K024085Device Name
CCD CAMERA, MODEL PKP-06000-000
Manufacturer
Date Cleared
2003-03-11
(90 days)
Product Code
Regulation Number
892.1620Why did this record match?
Product Code :
IZJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This Device is a Charged Coupled Device (CCD) camera for use in digital radiography, including DSA, high-resolution cardiology, and low dose fluoroscopy. It is designed for use with X-Ray image intensifiers in diagnostic imaging chains. The purpose of this device is to convert the visible image at the output of the X-Ray system image intensifier, to a video signal for display on a TV monitor.
Device Description
This Device is a Charged Coupled Device (CCD) camera for use in digital radiography, including DSA, high-resolution cardiology, and low dose fluoroscopy. It is designed for use with X-Ray image intensifiers in diagnostic imaging chains. The purpose of this device is to convert the visible image at the output of the X-Ray system image intensifier, to a video signal for display on a TV monitor.
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K Number
K972130Device Name
DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR
Manufacturer
Date Cleared
1997-10-09
(125 days)
Product Code
Regulation Number
892.1620Why did this record match?
Product Code :
IZJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Disposable X-Ray Cover is a sterile cover or drape for operative X-ray machine utilised during surgical procedures which require a sterile environment. It allows a surgeon to adjust and manoeuvre at will, without compromising the sterile field. The DXC provides a sterile barrier between the patient and the X-ray machine. Contaminants from the operative equipment (the X-ray machine) cannot penetrate through to infect the patient. Patient contaminants (such as blood and bodily fluids) cannot penetrate through to damage the machine. The DXC is disposable and single patient use only, so there is no cross contamination between patients. It is sterilised via gamma radiation. This product is marketed towards surgeons and hospitals concerned with the convenience and protection of covering an operative X-ray machine, so that it will not contaminate the sterile field.
Device Description
The Disposable X-Ray Cover is a sterile cover or drape for operative X-ray machines utilised during surgical procedures which require a sterile environment. It allows a surgeon to adjust and manoeuvre at will, without compromising the sterile field. As with most major surgical equipment, X-ray machines cannot be sterilised. It would damage them, rendering them useless. The Disposable X-Ray Cover provides a sterile barrier between the patient and the X-ray machine. Contaminants from operative equipment (the X-ray machine) cannot penetrate through to infect the patient. Patient contaminants (such as blood and bodily fluids) cannot penetrate through to damage the machine. The DXC is disposable and single patient use only, so there is no cross contamination between patients. It is sterilised via gamma radiation.
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