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510(k) Data Aggregation
K Number
K141364Device Name
CLIMB MAMMOGRAPHY VIEWER SOFTWARE
Manufacturer
Date Cleared
2014-08-29
(98 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
CLIMB MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Climb-Mammography Viewer is intended to be used by radiologists for the reading, manipulation and interpretation of DICOM digital breast images including mammography. Radiologists are able to select, display, manipulate, quantify, mark-up, print and exchange images.
Lossy compressed mammographic images must not be reviewed for primary image interpretations. Images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA for digital mammography. All images must conform to regulatory requirements. Image quality must conform to applicable quality guidance.
Device Description
Climb Mammography Viewer Software is breast imaging workstation software. The system allows for the display and manipulation of images that have been obtained from PACS or modalities. Source images are obtained as the recipient of push data for the images. The system can also automatically open images and the corresponding reporting page. The product includes features that allow the qualified medical professional to view patient medical images
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