Search Results
Found 1 results
510(k) Data Aggregation
K Number
K081899Device Name
ANYRAY PORTABLE X-RAY SYSTEM
Manufacturer
E-WOO TECHNOLOGY CO., LTD.
Date Cleared
2008-08-21
(49 days)
Product Code
EHD
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
E-WOO TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
"AnyRay" is Portable X-Ray System intended to be used by trained dentists and technicians as an extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.
Device Description
"AnyRay" is a wireless Portable X-Ray System that operates on DC22.5V supplied by a rechargeable Lithum-Polymer battery pack. The X-ray tubehead, X-ray controls and power source are ssembled into a single hand-held enclosure. The Package includes DC adaptor and Chair (Option) This equipment generates and controls X-ray in order to diagnose of tooth and jaw. It is composed of xray generator, controller, beam limiting device and chair (Option). Operating principle is that x-ay generated by high voltage electricity into x-ray tube, which (Openatifs primelpes in this x-ray images on receptor.
Ask a Question
Page 1 of 1