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510(k) Data Aggregation
K Number
K973744Device Name
UNICATH SP BI-PLANE (MODEL M269 & M289)
Manufacturer
Date Cleared
1997-12-29
(89 days)
Product Code
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
XRE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Unicath SP Biplane System is an Angiographic x-ray imaging system designed for those cardiac catheterization procedures requiring two simultaneous images of the heart and/or coronary arteries. Such systems are used to reduce the time necessary for complex adult cardiac catheterization studies, but they are particularly valuable in pediatric cardiology where biplane imaging allows reduced use of contrast material due to the need for fewer injections. This is a great advantage since contrast causes significant discomfort in children and carries with it an increased health risk for them. The System is designed to be operated by professional medical personnel only.
Device Description
The Unicath SP Biplane System is an Angiographic x-ray imaging system.
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K Number
K961193Device Name
FULL FRAME ZOOM SYSTEM
Manufacturer
Date Cleared
1996-06-17
(88 days)
Product Code
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
XRE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K960998Device Name
XRE COLLIMATOR
Manufacturer
Date Cleared
1996-04-03
(22 days)
Product Code
Regulation Number
892.1610Why did this record match?
Applicant Name (Manufacturer) :
XRE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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