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510(k) Data Aggregation
K Number
K101181Device Name
BEL-CAT
Manufacturer
Date Cleared
2011-07-19
(448 days)
Product Code
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
TAKARA BELMONT CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This is an x-ray device (cone beam computed tomography) that acquires a single 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support. The device is operated and used by physicians, dentists, and x-ray technologists. Not for mammographic use.
Device Description
The Bel-Cat series is a set of arm type X-ray CT diagnostic devices which has exposure modes can be customized to meet a wide variety of diverse diagnostic imaging needs. The Bel-Cat series is a true all-in-one system capable of offering diverse acquisition modes that deliver the high-definition images demanded in dental fields.
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K Number
K093240Device Name
BELRAY II
Manufacturer
Date Cleared
2010-03-22
(158 days)
Product Code
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
TAKARA BELMONT CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BELRAY II, Model 097 is a extraoral source dental radiographic x-ray unit. This unit works as a diagnostic purpose x-ray source for human teeth with the resultant image recorded on intraoral dental x-ray film or image receptor.
Device Description
extraoral source dental radiographic x-ray unit
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K Number
K072574Device Name
ALPHARD CONE BEAM CT, MODEL X178
Manufacturer
Date Cleared
2007-10-18
(35 days)
Product Code
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
TAKARA BELMONT CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Alphard Model X178 is an x-ray device (cone beam computed tomography) that acquires a single 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support. The device is operated and used by physicians, dentists, and x-ray technologists.
Device Description
Alphard series 3D X-ray CT realizes wide area imaging by adopting the principle of cone beam CT and using high-resolution wide area flat panel detector (FPD). Alphard series enables dentist to take wide range imaging from small area to wide area with appropriate imaging mode according to various treatment objects. Combination of advanced FPD (dynamic range: 14bit) and micro focus X-ray tube provides high resolution CT image from soft tissue to hard tissue. Our original software AsahiVision freely displays high picture quality 3D image and MPR image.
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