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510(k) Data Aggregation
K Number
K042372Device Name
HDS INTRA-ORAL IMAGING SYSTEM
Manufacturer
Date Cleared
2004-10-04
(34 days)
Product Code
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
VATECH VALUE ADDED TECHNOLOGY CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
"HDS" Intra-oral Imaging System is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.
Device Description
The Intra-oral image system (HDS) is a device for digital intra oral X-rays imaging. It is fully USB compliant and can be plugged in any when computer is turned on.
Intra-oral image system (HDS) block diagram
PC
· Image interface box (Read-out Box)
· X-ray sensor
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