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510(k) Data Aggregation
K Number
K192766Device Name
Digital Intraoral Imaging Plate System
Manufacturer
Date Cleared
2019-12-05
(66 days)
Product Code
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
Fsusen Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Digital Intraoral Imaging Plate System is indicated for capturing, digitization and processing of intraoral x-ray images stored in imaging plate recording media.
And it is intended for uses in hospitals and clinics, and shall be operated and used by trained professionals with physician's guidance.
Device Description
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