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510(k) Data Aggregation
K Number
K161188Device Name
HEPATIQ 1.1
Manufacturer
Date Cleared
2016-06-09
(43 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
HEPATIQ LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
HEPATIQ is a nuclear medicine software application used to display and process liver-spleen images. The results obtained may be used as a tool, by a nuclear physician, in quantifying liver-spleen images. The data processed may be derived from any nuclear medicine liver-spleen procedure. The HEPATIQ software should only be used by qualified nuclear medicine professionals.
Device Description
HEPATIQ is a nuclear medicine software application used to display and process liver-spleen images.
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K Number
K142891Device Name
HEPATIQ
Manufacturer
Date Cleared
2014-12-17
(75 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
HEPATIQ LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
HEPATIQ is a nuclear medicine software application used to display and process liver-spleen images. The results obtained may be used as a tool, by a nuclear physician, in quantifying liver-spleen images. The data processed may be derived from any nuclear medicine liver-spleen procedure. The HEPATIQ software should only be used by qualified nuclear medicine professionals.
Device Description
HEPATIQ is Microsoft Windows software that allows the user to display and process nuclear medicine liver-spleen images. HEPATIQ software runs on any nuclear medicine workstation running Windows XP SP3 or later. HEPATIQ software provides the user a means for quantification of nuclear medicine liver-spleen images.
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