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510(k) Data Aggregation
K Number
K091288Device Name
MEDI-6000 MEDICAL IMAGE DIGITIZER
Manufacturer
MICROTEK INTERNATIONAL, INC.
Date Cleared
2009-08-14
(105 days)
Product Code
LMA
Regulation Number
892.2030Why did this record match?
Applicant Name (Manufacturer) :
MICROTEK INTERNATIONAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medi-6000 consists of a transparency film digitizer and paper CCD scanner that is used to digitize radiographs or X-ray film as well as paper reports or doctor's orders. When the Medi-6000 is used to digitize radiographic films, the digital image is intended for use in primary, secondary and over reading applications. This device is not to be used for primary image diagnosis in mammography. The target users of the device are medical professionals or trained staffs.
Device Description
The Medi-6000 is a digitizer that can easily transfer x-ray films into a digital format for patients, hospitals, and office records. It can capture details in bright and dark areas of x-ray films and provide the medical professionals a convenient method to digitize the roentgenogram for the electric data storage.
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