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510(k) Data Aggregation
K Number
K053039Device Name
CLINTON ELECTRONICS SERIES II DIGITAL GRAYSCALE MONITORS, MODELS DL2000, DL3000, DL2000 OF AND DL3000 OF
Manufacturer
Date Cleared
2006-03-01
(125 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
CLINTON ELECTRONICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Clinton Electronics Corp. DL Series II Flat-Panel Displays are intended for use in displaying and viewing digital images by trained medical practitioners. The Displays are not intended for and should not be used for primary diagnosis in digital mammography.
Device Description
The DL Series II Displays are Digital Monochrome LCD flat panel displays. The series II are capable of Displaying 2 mega-pixel and 3 mega-pixel formats dependent upon model type.
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