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510(k) Data Aggregation
K Number
K083618Device Name
PACS SCAN
Manufacturer
Date Cleared
2009-01-28
(51 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
PACSGEAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PacsSCAN Medical Imaging Software with QC Module is intended to be used by authorized staff to perform various quality control operations on PACSGEAR imaging studies before they are made available to other locations in the network. These operations include scanning film images, capturing video images, confirming or editing patient demographics, reviewing the history of the study, adding or removing images, combining with another study, renumbering images, editing patient orientation information, and setting or editing routing information.
Device Description
The PacsSCAN Medical Imaging Software with OC Module is intended to be used by authorized staff to perform various quality control operations on PacsSCAN imaging studies before they are made available to other locations in the network. These operations include digitizing film images, capturing video images, confirming or editing patient demographics, reviewing the history of the study, adding or removing images, combining with another study, renumbering images, editing patient orientation information, and setting or editing routing information.
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