intended_use_and_certification_status
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intended_use_and_certification_status [2023/11/29 17:52] rudy created |
intended_use_and_certification_status [2023/11/30 15:44] (current) rudy [Intended purpose] |
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| + | ====== Intended use and certification status ====== | ||
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| PIMS use the PMA.core technology and User Interface to guarantee diagnostic accuracy | PIMS use the PMA.core technology and User Interface to guarantee diagnostic accuracy | ||
| - | ===== Intended purpose ===== | + | ==== Intended purpose ==== |
| PMA.core 3.0 is a software platform for managing, distributing, viewing and annotating digital images of human | PMA.core 3.0 is a software platform for managing, distributing, viewing and annotating digital images of human | ||
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| relevant to making a diagnosis the pathologist annotated on these images. | relevant to making a diagnosis the pathologist annotated on these images. | ||
| - | ===== Intended purpose ===== | + | ==== Intended Users ==== |
| PMA.core 3.0 is intended for professional use by pathologists. | PMA.core 3.0 is intended for professional use by pathologists. | ||
| - | ===== Compliance and clinical performance ===== | + | ==== Compliance and clinical performance ==== |
| PMA.core 3.0 complies with the provisions of EU Directive 98/79/EC on in vitro diagnostic medical devices. | PMA.core 3.0 complies with the provisions of EU Directive 98/79/EC on in vitro diagnostic medical devices. | ||
intended_use_and_certification_status.1701269554.txt.gz ยท Last modified: 2023/11/29 17:52 by rudy
