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510(k) Data Aggregation
K Number
K081215Device Name
VOLUMINA
Manufacturer
Date Cleared
2008-08-26
(118 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
KJAYA MEDICAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Volumina enables the display of 3D (MIP/MPR) visualization of CT, PET, and MR studies or other DICOM compliant images. Typical users are radiologists, technologists and clinicians. Not for mammographic purposes.
Device Description
Volumina is a Class II software application comprised of a client module and a server module. Volumina is intended to provide a diagnostic quality image to a qualified health care professional to visualize multimodal medical image data.
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