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510(k) Data Aggregation
K Number
K043136Device Name
ELITY 70 X-RAY
Manufacturer
Date Cleared
2005-01-06
(55 days)
Product Code
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
DENTAL X-RAY E.U.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Elity 70 X-Ray is an extra oral source X-Ray system for dental radiographic examination and diagnosis of diseases of the teeth. The unit is intended for use in the dental clinic environment and used by trained dentists and/or assistants.
Intended Use for the Elity 70 X-Ray Unit: The Elity 70 is an extraoral device designed to expose intraoral X-ray recording media (Film, plates, sensors) for the purpose of radiographic examination and diagnosis of the teeth.
Device Description
The Elity 70 X-ray Unit is a traditional extra oral radiographic system, designed to face the most demanding needs of the dental profession both when using traditional films and digital imaging receptor. The system voltage potential of 70kVp and the anodic current of 10 mA, the small focal spot, the beam limiting device with effective near focus collimation, and the penetration power of a 70 kVp radiation beam make the best combination of which grant sharp images. The Elity 70 X-Ray wall mounted system feature short, medium, and long extension arms giving a useful reach up to 185 cm when combined with the folding arm. The system comes with an Auto Set timer thus offering the best flexibility of use. Common functionality include a green light for "system ready", a vellow light and a buzzer for "radiation emission, and a red light for "faulty condition"; each timer and each hand switch can be remotely mounted. The high voltage generator is enclosed in a cover. A circular cone with a maximum diameter of 60 mm forms the beam-limiting device. The weight of the tubehead is 7.5 kg. The certified components may be assembled in different configurations in terms of arms and mounting.
Auto Set electronic timer microprocessor controlled, with flat keyboard; automatic setting of exposure time from 0.1 ms to 3.0 through objectprogrammed selection according to tooth type and patient size. Elity 70 extraoral X-ray equipment is composed of the following parts:
- I. Fixed and Scissor Arms.
- Tubehead with Beam Limiting Device. II.
- III. Control Panel (Timer)
- IV. Wall Mount Kit- Single post 16" Center Wall Plate.
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