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510(k) Data Aggregation
K Number
K052136Device Name
GR17 DIGITAL DETECTOR
Manufacturer
Date Cleared
2005-08-25
(20 days)
Product Code
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
ANRAD CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The GR17 is a selenium-based direct conversion DR detector intended for use by a qualified/trained doctor or technician and is designed to perform radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. The GR17 is not used for mammography.
Device Description
The GR17 is a 17" x 17" Flat Panel Digital Radiographic Detector for General Radiographic Use. It uses amorphous Selenium (a-Se) as the primary photoconductor.
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K Number
K042821Device Name
DIGITAL DETECTOR, MODEL GR17
Manufacturer
Date Cleared
2004-10-22
(10 days)
Product Code
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
ANRAD CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The GR17 is an amorphous Selenium-based direct conversion Digital Radiography (DR) detector intended for use by a qualified/trained doctor or technician and is designed to generate radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
Device Description
The GR17 is a 17 inch by 17 inch digital delector. It is intended to convert X-rays into efectrical signals to create usable images for diagnostic use.
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