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510(k) Data Aggregation
K Number
K983283Device Name
SIGNET DXIS DIRECT X-RAY IMAGING SYSTEM
Manufacturer
SIGNET RADIOLOGY, INC.
Date Cleared
1998-11-06
(49 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
SIGNET RADIOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
THE DXIS® IS INTENDED FOR DENTAL RADIOGRAPHIC EXAMINATION AND DIOGNOSIS OF DISEASES OF THE TEETH, JAW AND ORAL STRUCTURE.
Device Description
The Signet DXIS® System is designed to replace the film cassettes with a digital sensor in existing dental panoramic x-rav systems that are already on the market. It consists of a digital x-ray sensor. interface equipment, software, and adapters for specific dental x-ray systems. The DXIS® is installed by a Signet authorized technician on existing compatible dental x-ray systems. Software provided by Signet and a user supplied computer permit the images from the digital sensor to be recorded and displayed.
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