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510(k) Data Aggregation
K Number
K162619Device Name
I View and Imagen Sensor
Manufacturer
TRIDENT S.R.L.
Date Cleared
2016-11-04
(45 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
TRIDENT S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
I-View dental sensor is used for a radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral structures.
Device Description
The subject device I View is an intraoral digital x-ray systems comprised of two components: (1) an intraoral detector which connects to a PC via a USB port; and (2) an Image Mangement Software package.
The subject devices comes in two sizes: Size 1 is 600mm² and Size 2 is 884mm².
The Size 1 sensor is also known as factory code S11684-12; Size 2 sensor is known as factory code S116845-12. I View and Imagen Sensor will both have Size 1 and Size 2. Two different trade names are for marketing purposes.
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