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510(k) Data Aggregation
K Number
K060179Device Name
BIO-RAY SDX DIGITAL X-RAY SYSTEM
Manufacturer
SIGMA BIOMEDICS, INC.
Date Cleared
2006-02-08
(16 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
SIGMA BIOMEDICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BIO-RAY SDX digital x-ray system is intended to be used with standard x-ray systems to collect dental x-ray photos and convert them into electronic data that may be stored, viewed, and manipulated by dentists for the diagnosis of the tecth, jaw and oral structures with the use of computer imaging sollware provided by other 30 parties, readily available from numerous sources.
This device is only to be sold as a prescription device sold to doctors or dental dealers selling directly to doctors,
Device Description
Digital Dental Intraoral X-Ray Sensor This device is intended to be used for the dental radiographic examination for the diagnosis of diseases of the teeth, jaw, and oral structures.
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