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510(k) Data Aggregation
K Number
K002146Manufacturer
Date Cleared
2000-09-27
(72 days)
Product Code
Regulation Number
892.2040Type
TraditionalPanel
RadiologyReference & Predicate Devices
N/A
Why did this record match?
Device Name :
KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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