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510(k) Data Aggregation
K Number
K051664Device Name
SCAN300FP / RETROPAN (VDC)
Manufacturer
OY AJAT, LTD.
Date Cleared
2005-07-20
(28 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
OY AJAT, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Scan300fp / Retropan (VDC) Digital X-ray Conversion Kit is used to provide instant x-ray images of human oral tissue and teeth without the use of conventional x-ray films.
The Scan300fp sensor produces instant digital images. The Scan300fp allows the use of less exposure time than with conventional films, thus lowering patient dose. The sensor is connected to the DentalEye software, #K012439, which gives post processing capabilities to enhance images.
lt is faster to obtain images with the Scan300fp / Retrofit (VDC) than with conventional film since no chemical nor any other type of processing is required.
Device Description
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