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510(k) Data Aggregation
K Number
K964438Device Name
511 KEV COLLIMATOR
Manufacturer
Date Cleared
1997-05-29
(205 days)
Product Code
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
TRIONIX RESEARCH LABORATORY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To detect or image the distribution of radionuclides in the body or in organ, using the following technique(s): Planar imaging, Whole body imaging, Tomographic imaging (SPECT) for non Positron emitter, Positron imaging without coincidence. Could be used with 511 keV photo imaging and photons of smaller energy simultaneously (e.g. 140 keV and 511 keV).
Device Description
511 keV Collimator for TRIONIX Triad
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K Number
K962481Device Name
QUASAR RECOVERY IMAGING PACKAGE
Manufacturer
Date Cleared
1996-11-27
(154 days)
Product Code
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
TRIONIX RESEARCH LABORATORY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K964265Device Name
CARDIAC TRIAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM
Manufacturer
Date Cleared
1996-11-12
(19 days)
Product Code
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
TRIONIX RESEARCH LABORATORY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K964266Device Name
BIAD NUCLEAR IMAGING SYSTEM
Manufacturer
Date Cleared
1996-11-12
(19 days)
Product Code
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
TRIONIX RESEARCH LABORATORY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K964267Device Name
MONAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM
Manufacturer
Date Cleared
1996-11-12
(19 days)
Product Code
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
TRIONIX RESEARCH LABORATORY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K964268Device Name
TRIAD 88 NUCLEAR IMAGING SYSTEM
Manufacturer
Date Cleared
1996-11-12
(19 days)
Product Code
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
TRIONIX RESEARCH LABORATORY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K961597Device Name
GATED MIBI 3-D EJECTION FRACTION PROCESSING
Manufacturer
Date Cleared
1996-09-04
(133 days)
Product Code
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
TRIONIX RESEARCH LABORATORY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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