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510(k) Data Aggregation
K Number
K031448Device Name
RSV (RADIOLOGY SYSTEM VISIODENT
Manufacturer
VISIODENT SA
Date Cleared
2003-07-31
(85 days)
Product Code
EHD
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
VISIODENT SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RSV (Radiology System Visiodent) device is used to provide instant images of x-rayed human oral tissue and teeth without the use of conventional x-ray films.
This is achieved by using the conventional x-ray tube, but by placing an electronic sensor, instead of film, inside the patient's mouth. The sensor, upon radiation exposure, automatically captures the images into a computer for viewing, storage, printing and manipulation of the x-rays.
Device Description
The RSV (Radiology System Visiodent) device is used to provide instant images of x-rayed human oral tissue and teeth without the use of conventional x-ray films.
This is achieved by using the conventional x-ray tube, but by placing an electronic sensor, instead of film, inside the patient's mouth. The sensor, upon radiation exposure, automatically captures the images into a computer for viewing, storage, printing and manipulation of the x-rays.
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