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510(k) Data Aggregation
K Number
K101391Device Name
SCANDIA-45 GAMMA CAMERA SYSTEM
Manufacturer
Date Cleared
2010-08-04
(78 days)
Product Code
Regulation Number
892.1100Why did this record match?
Applicant Name (Manufacturer) :
SCANDIA CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For use in the acquisition, processing, display, and analysis of planar images of the thyroid and other small organs.
Device Description
The Scandia-45 is a high resolution, SFOV digital gamma camera for thyroid and small organs imaging. The Scandia-45, is made up of a single, small-field detector assembled with high optical and mechanical quality. The systems has 45 high quantum efficiency photomultipliers characterized by improved energy resolution, magnetic shielding and long-term stability and utilizes a compact, highly integrated, one board, easily serviceable construction without tuning potentiometers. The acquisition console has full-digital electronics, including fast PCI bus acquisition interface. The system also has a light-weight, easilyadjustable gantry and light, easily-exchangeable microcast collimators.
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