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510(k) Data Aggregation
K Number
K020643Device Name
EZ-SCOPE AN & EZ-SCOPE AN LITE
Manufacturer
HEALTH POLICY RESORTERS GROUP, LLC
Date Cleared
2002-05-28
(90 days)
Product Code
IYX
Regulation Number
892.1100Why did this record match?
Applicant Name (Manufacturer) :
HEALTH POLICY RESORTERS GROUP, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Anzai eZ-Scope AN Portable Gamma Camera is indicated for use to image the distribution of radionuclides in the human body using planar imaging techniques. The eZ-Scope may be used on pathological specimens if a protective sheath is used.
Device Description
The Anzai eZ-Scope AN Portable Gamma Camera is a new and innovative portable gamma camera. The camera utilizes a solid state detector, rather than a scintilator, to detect gamma rays. The cadmium-zinc-tellurium detector allows sharp energy discrimination and spatial resolution.
The detector array is made from pixelized cadmium-zinc-telluride (CZT) crystals, with each of the 256 pixels having dimensions of 2 x 2 mm.
The system will be available in two configurations, eZ-Scope AN and eZ-Scope Life. These differ primarily in the computer, the former model using a desktop computer and the latter a laptop. In the desktop version, the computer is mounted on a cart, while the laptop version does not have a cart.
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