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510(k) Data Aggregation
K Number
K021718Device Name
INTRAORAL IMAGING SYSTEM, MODEL SUNI-RAY
Manufacturer
SUNI IMAGING MICROSYSTEMS, INC.
Date Cleared
2002-08-15
(84 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
SUNI IMAGING MICROSYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Suni Digital Radiography System is used to collect dental x-rays photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.
Device Description
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