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510(k) Data Aggregation
K Number
K984332Device Name
SPECTRA VU 1000 SERIES INTRAORAL CAMERA, SPECTRA VU 2000 SERIES INTRAORAL CAMERA, SPECTRA VU HDDI SV I INTRAORAL CAMERA,
Manufacturer
INTERNATIONAL TECHNOLOGY CONCEPTS
Date Cleared
1999-04-29
(147 days)
Product Code
EIA
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
INTERNATIONAL TECHNOLOGY CONCEPTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SpectraVu Family of Intracral Cameras are intended for use in dentistry to provide a view of the oral cavity and contents as an aid in explaining and demonstrating conditions to patients. These also provide an enlarged view of areas for the dentist to better identify defects. Images can be stored for future reference.
These cameras are not intended for use as an operative device. The camera and components are not manufactured to be sterile, however the metallic sleeve tip with the glass optical window is designed to be sterilized between uses, and/or may be protected by commercially available plastic disposable sleeves,
Device Description
The SpectraVu Family of Intraoral Camera Systems . consist of a power supply, digital camera processor, circuit boards, a light source, optical and electronic cables, and an ergonomic hand piece with an autoclavable sleeve containing an optical system. The components are capable of capturing images over a wide focal range. The images can be displayed on a television monitor, in a computer or may be printed out.
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