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510(k) Data Aggregation
K Number
K142647Device Name
mint Lesion
Manufacturer
MINT MEDICAL GMBH
Date Cleared
2015-04-13
(208 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
MINT MEDICAL GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Mint Lesion is a software solution intended to be used for viewing, manipulation, storage, 3Dvisualization and comparison of medical images from multiple imaging multiple time-points. Mint Lesion is a software only medical device which will be delivered on CDROM / DVD to be installed by trained service personnel.
Mint Lesion is a medical diagnostic application for viewing, manipulation and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MPR, MIP and volume rendering.
Mint Lesion enables visualization of information that would otherwise have to be visually compared disjointedly. Mint Lesion provides analytical tools to help the user assess, and document the stage of a disease and/or the response to therapy in accordance with user selected standards. Mint Lesion supports the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Oncology, and Nuclear Medicine environments.
Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. Mint Lesion is a complement to these standard procedures. Mint Lesion is not to be used in mammography.
Device Description
mint Lesion™ is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and visualization of medical image data. It runs on either a native or a virtualized Microsoft Windows platform.
mint Lesion™ functionality provides for communication, storage, processing, rendering, and display of DICOM compliant image data derived from various sources including anatomical datasets (e.g. CT, MRI) and functional datasets (e.g. PET), lesion measurement, tabulation and summation of measurements, lesion categorization and standard evaluation in accordance with radiological staging and response criteria, and generation of a structured report. The user controls these functions with a system of interactive menus and tools.
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