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510(k) Data Aggregation
K Number
K132684Device Name
MEDWS SOFTWARE (VARIANTS MEDVIEW, MEDDIAG, MEDMAMMO)
Manufacturer
Date Cleared
2014-05-23
(268 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
MEDECOM SARL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MEDWS Software (MEDVIEWS, MEDMAMMO) is intended for selection, display, manipulation and media interchange of medical images, including mammograms. It can show images from different modalities and interfaces to various image storage and printing device using DICOM or similar interface standards.
Lossy compressed mammographic image are not intended for diagnostic images should only be viewed with a monitor cleared by FDA for viewing mammographic images. For primary diagnosis, post process DICOM for presentation images must be used.
The MEDWS Software (MEDVIEWS, MEDDIAG, MEDMAMMO) is typically used by trained professionals including but not limited to physicians, radiologists, nurses, medical technicians and assistants.
Device Description
The MEDWS software range offers solutions for managing radiology images and reviewing them for diagnostic purposes. They are used in hospital or clinic radiology departments and in private medical imaging practices. They are used by radiologists for all functions and by technicians for functions not involving diagnoses (formatting for printing, CD burning, etc. ). A solution from the MEDWS software range is installed on a computer connected to the imaging network. The radiology table (modality) manages image acquisition and sends images over the local network to a console from the MEDWS range.
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