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510(k) Data Aggregation
K Number
K023292Device Name
APEX HRI DIGITAL RADIOGRAPHY SYSTEM
Manufacturer
Date Cleared
2002-12-13
(72 days)
Product Code
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
KRUGMAN TECHNOLOGIES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Apex HRI Digital Radiography System is designed to replace standard intraoral xray film and film development chemicals used for patient diagnostics in dental practices.
Device Description
Digital dental Intraoral Xray sensor
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