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510(k) Data Aggregation
K Number
K220689Device Name
Vatech Clismile
Manufacturer
Rayence Co.,Ltd
Date Cleared
2022-05-06
(58 days)
Product Code
NJM
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
Rayence Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vatech Clismile is indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.
Device Description
This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth.
It is used to correct teeth by transmitting physical force to each tooth, and is a selfligation bracket using a ceramic body and a metal cap made of a metal material. Shelf-life is not applicable because of the low likelihood of time-dependent product degradation.
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K Number
K183478Device Name
ClearON Mobile
Manufacturer
Rayence Co.,Ltd
Date Cleared
2019-03-01
(74 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Rayence Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Clear On Mobile software carries out the image processing and administration of medical X-ray data which includes adjustment of window leveling, rotation, zoom, and measurements. Clear on Mobel is not approved for mammography and is meant to be used by qualified medical personnel only. Clear On Mobile is complying with DICOM standards to assure optimum communications between network systems.
Device Description
ClearON Mobile provides easy touch based user interface to perform diagnosis of digital radiograph images displayed on ClearOn Mobile. ClearON Mobile receives digital images from a flat panel detector and a X-ray generator. The software also manages patient data, stores and transfers diagnostic images in an internal database.
It supports DICOM image file format which allows interoperability with other Radiography equipment in network environment.
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