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Found 4 results
510(k) Data Aggregation
K Number
K231181Device Name
bright CT
Manufacturer
Dentium Co., Ltd (ICT Branch)
Date Cleared
2023-12-14
(232 days)
Product Code
OAS
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
Dentium Co., Ltd (ICT Branch)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
bright CT is a computed tomography x-ray system intended to produce 3D, panoramic, and cephalometric diagnostic images of the maxillofacial areas for treatment planning for adult and pediatic patients. The device is operated and used by physicians, dentists, and x-ray technicians.
Rainbow 3D Image Viewer software functions for acquiring, saving, searching, displaying, diagnosing and sending digital X-ray image data in dental practices and clinics.
Device Description
bright CT is a cone beam CT X-ray device for generating sectional images of dental images such as tooth, nasal cavity and temporomandibular joint. this is a medical diagnostic equipment designed to generate sectional images by placing X-ray source opposite to the imaging detector unit and rotating it around a patient. 2D images of the region of interest are reconstructed using a mathematical algorithm in 3 dimensional volumetric view and displayed on the computer monitor.
The system is composed of X-ray generator, X-ray detector, X-ray collimator, main frame, rotation unit, PC and Monitor, etc. in compliance with US performance standard and regulatory requirement.
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K Number
K200270Device Name
rainbow MCT
Manufacturer
Dentium Co., Ltd (ICT Branch)
Date Cleared
2021-04-16
(437 days)
Product Code
OAS
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
Dentium Co., Ltd (ICT Branch)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
rainbow MCT is a computed tomography x-ray system intended to produce 3D and panoramic diagnostic images of the maxillofacial areas for treatment planning for adult and pediatric patients. The device is operated and used by physicians, dentists, and x-ray technicians.
Rainbow 3D Image Viewer software functions for acquiring, saving, searching, displaying, diagnosing and sending digital X-ray image data in dental practices and clinics.
Device Description
rainbow MCT is a cone beam CT X-ray device for generating sectional images of dental images such as tooth, nasal cavity and temporomandibular joint. this is a medical diagnostic equipment designed to generate sectional images by placing X-ray source opposite to the imaging detector unit and rotating it around a patient. 2D images of the region of interest are reconstructed using a mathematical algorithm in 3 dimensional volumetric view and displayed on the computer monitor.
The system is composed of X-ray generator, X-ray detector, X-ray collimator, main frame, rotation unit, PC and Monitor, etc. in compliance with US performance standard and regulatory requirement.
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K Number
K200271Device Name
rainbow CT
Manufacturer
Dentium Co., Ltd (ICT Branch)
Date Cleared
2021-04-16
(437 days)
Product Code
OAS
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
Dentium Co., Ltd (ICT Branch)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
rainbow CT is a computed tomography x-ray system intended to produce 3D, panoramic, and cephalometric diagnostic images of the maxillofacial areas for treatment planning for adult and pediatric patients. The device is operated and used by physicians, dentists, and x-ray technicians.
Rainbow 3D Image Viewer software functions for acquiring, saving, searching, displaying, diagnosing and sending digital X-ray image data in dental practices and clinics.
Device Description
rainbow CT is a cone beam CT X-ray device for generating sectional images of dental images such as tooth, nasal cavity and temporomandibular joint. this is a medical diagnostic equipment designed to generate sectional images by placing X-ray source opposite to the imaging detector unit and rotating it around a patient. 2D images of the region of interest are reconstructed using a mathematical algorithm in 3 dimensional volumetric view and displayed on the computer monitor.
The system is composed of X-ray generator, X-ray detector, X-ray collimator, main frame, rotation unit, PC and Monitor, etc. in compliance with US performance standard and regulatory requirement.
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K Number
K201247Device Name
Intraoral Sensor
Manufacturer
Dentium Co., Ltd (ICT Branch)
Date Cleared
2020-06-10
(30 days)
Product Code
MQB, MUH
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
Dentium Co., Ltd (ICT Branch)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intra Oral Sensor (model: IOX 1 / IOX 2) is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, views and manipulated for diagnostic use by dentists.
Device Description
Intraoral Sensor (model: IOX 1 / IOX 2) by Dentium is a medical device that acquires digital images by detecting subject information through X-rays and converting them into electrical image signals to identify teeth and tissues in the mouth. The product consists of the Intraoral Sensor, USB Memory, Sensor Holder, Silicon Cover and Quick Guide.
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