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510(k) Data Aggregation
K Number
K063391Device Name
SAPHENEIA CLARITY
Manufacturer
SAPHENEIA COMMERCIAL PRODUCTS AB
Date Cleared
2007-04-26
(168 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
SAPHENEIA COMMERCIAL PRODUCTS AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sapheneia Clarity is intended for use by radiologists for transfer, storage, noise reduction, contrast enhancement and viewing of multi-modality images from a variety of diagnostic systems. The device is also intended to be used by trained/qualified technologists for installation and maintenance of the software. For your legal protection, it is strongly recommended that you backup your original data.
For digital mammography, only DICOM 'For Presentation' images should be displayed for primary image diagnosis
Device Description
The Sapheneia Clarity™ image processing software reduces noise and enhances contrast of relevant structures to increase image quality through structure adaptation, tissue adaptation, scale adaptation, and noise adaptation. Sapheneia Clarity™ employs a sophisticated statistical analysis of the image structure in the neighborhood of each pixel. Using robust estimation methods the dominant structures are separated from the embedding noise. Once the structure has been determined, it is possible to strengthen the interesting parts while simultaneously reducing the noise. The acquisition remains the same, i.e. the image processing can be generated from multiple modalities and with predefined or specific acquisition protocol settings.
The workflow of Sapheneia Clarity™ image enhancement system can be easily adapted to existing radiology departmental workflow. Sapheneia Clarity™ acts as a DICOM node that receives DICOM3.0 digital medical image data from the modality or another DICOM source, processes the data and then forwards the enhanced and/or original study to the selected destination. This destination can be any DICOM node, typically either the PACS system or a specific workstation.
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