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510(k) Data Aggregation
K Number
K171485Device Name
BSD4343R Digital Flat Panel X-ray Detector
Manufacturer
Date Cleared
2017-06-21
(30 days)
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
Bontech Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BSD4343R Digital Flat Panel X-ray Detector (Model: BT-DA24-IA) is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system in all general-purpose diagnostic procedures. It is not to be used for mammography.
Device Description
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K Number
K162487Device Name
BSD3543 Digital Flat Panel X-ray Detector
Manufacturer
Date Cleared
2016-10-14
(37 days)
Product Code
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
BONTECH INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BSD3543(BT-DA22-IA) detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system in all general-purpose diagnostic procedures. It is not to be used for mammography.
Device Description
BSD3543(BT-DA22-IA/BT-DB22-IA) is a digital X-ray flat panel detector which intercepts x-ray photons and the scintillator (BT-DB22-IA(Gdos) / BT-DA22-IA(CsI)) emits visible spectrum photons that illuminate an array of photo (a-SI)-detector that creates electrical signals. After the electrical signals are generated, it is converted to digital values, and the images will be displayed on the monitor. This device should be integrated with an operating PC and an X-Ray generator. It can digitalize x-ray images and transfer them for radiography diagnostics. Advanced digital image processing allows considerably efficient diagnosis, all kinds of information management, and sharing of image information on network.
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K Number
K160204Device Name
BSD4343 Digital Flat Panel X-ray Detector
Manufacturer
Date Cleared
2016-06-09
(133 days)
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
BONTECH INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BSD4343 detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system in all general-purpose diagnostic procedures. It is not to be used for mammography.
Device Description
BSD4343 is a digital X-ray flat panel detector which intercepts x-ray photons and the scintillator (Gadox:Tb type) emits visible spectrum photons that illuminate an array of photo (a-SI)-detector that creates electrical signals. After the electrical signals are generated, it is converted to digital values, and the images will be displayed on the monitor. This device should be integrated with an operating PC and an X-Ray generator. It can digitalize x-ray images and transfer them for radiography diagnostics. Advanced digital image processing allows considerably efficient diagnosis, all kinds of information management, and sharing of image information on network.
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