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510(k) Data Aggregation
K Number
K013138Device Name
ADC COMPACT PLUS
Manufacturer
AGFA-GEVAERT AG
Date Cleared
2001-09-28
(9 days)
Product Code
MQB, MOB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
AGFA-GEVAERT AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ADC Compact Plus is indicated for use to provide diagnostic quality images to aid in physician diagnosis. The ADC Compact Plus is intended to be used mainly in chest, skeletal, and gastro-intestinal x-ray imaging applications.
Device Description
The ADC Compact Plus is similar to the ADC Compact, but it has a different laser and smaller spot size for improved resolution and higher sensitivity. An improved detector improves the throughout. The electronics are being reorganized and made smaller, which will result in lower power requirements. However, the basic principles of operation are unchanged. The components that implement these principles of operation are simply being upgraded with better components that are now available.
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