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Found 2 results
510(k) Data Aggregation
K Number
K030457Device Name
REX, VERSION 3.0
Manufacturer
POINTDX, INC
Date Cleared
2003-04-08
(56 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
POINTDX, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
REX™ 3.0 is a software package intended for viewing and manipulating DICOM-compliant medical images acquired from CT and MR scanners. REX™ 3.0 can be used for real-time image viewing, image manipulation, 3D volume rendering, virtual endoscopy, and issuance of reports.
Device Description
REX™ 3.0 is a tool for 3D (three dimensional) and 2D (two dimensional) viewing and manipulation of DICOM compliant CT and MR images. The proposed software provides real-time image viewing, image manipulation, 3D volume rendering, virtual endoscopy, and issuance of reports.
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K Number
K021099Device Name
REX, VERSION 1.0
Manufacturer
POINTDX, INC
Date Cleared
2002-06-27
(84 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
POINTDX, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
REX™ 1.0 is a software package intended for viewing and manipulating DICOM-compliant medical images acquired from CT scanners. REX™ 1.0 can be used for real-time image viewing, image manipulation, 3D volume rendering, virtual endoscopy, and issuance of reports.
Device Description
REX™ 1.0 is a tool for 3D (three dimensional) and 2D (two dimensional) viewing and manipulation of DICOM compliant CT images. The proposed software provides real-time image viewing, image manipulation, 3D volume rendering, virtual endoscopy, and issuance of reports.
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