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510(k) Data Aggregation
K Number
K051127Device Name
KIKA IMAGING LAB VIEWER, MODEL 2.0.1.0
Manufacturer
Date Cleared
2005-06-03
(31 days)
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
KIKA MEDICAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
KIKA Imaging Lab is intended to be used for diagnostic image management, archiving, annotation, acceptance, transfer, display, storage, image processing of diagnostic ultrasound, CD, MRI, and X-ray images, including manipulation, compression and quantification of images.
The KIKA Imaging Lab brings is typically used in web data sharing domains, especially in clinical trial management, post marketing surveillance, adverse event management, tele-expertise or telemedicine.
When interpreted by a trained physician, reviewed images can be used as an element for diagnosis.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Device Description
The KIKA Imaging Lab is a Web-based medical image and workflow management system that allows reviewing, manipulating, interpreting, archiving and interchanging medical multi-modality image in the DICOM format. The functions of this workflow management system provide image viewing and manipulation in a diagnostic imaging setting. KIKA Imaging Lab Viewer is a secured web communication platform, to handle image management needs between all users of web clinical trials (investigators, experts, data managers etc.). The investigator may upload images from a CD source to a web based patient database, add annotations, adjusts display of images, scroll all the images of a DICOM series, and show cine playbacks.
Images are stored in a DICOM 3.0 compliant format using various different standard compression methods. Parameters and measurements are saved into a file attached to the image on the remote server. The original image is never altered.
The expert can then review images in a DICOM browser interface, retrieve images to local hard disc, do measurements (calibration, distance, area, angle) and display images in double view layout useful to compare images from different visits or series.
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