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510(k) Data Aggregation
K Number
K983392Device Name
DATA RAY CORPORATION DR11021 MEDICAL IMAGING MONITOR
Manufacturer
Date Cleared
1998-12-15
(81 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
DATA RAY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Data Ray Corporation DR11021 Medical Imaging Monitor is intended to be used by radiologists/trained practitioners to examine digitized x-ray images for the purpose of medical analysis.
The Data Ray Corporation DR11021 Medical Imaging Monitor is used in filmless radiology systems to display digitized x-ray images. These digitized x-ray images are viewed by trained medical providers for the purpose of diagnosing and/or treating illnesses in human beings.
Device Description
The DR11021 Medical Imaging Monitor is a diagnostic display used in film-less radiology applications.
The Data Ray Corporation DR11021 Medical Imaging Monitor is a high resolution monitor with the electronic capability necessary for displaying high resolution medical images for the purpose of evaluation.
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