Pathomation’s PMA.core version 3.0.0. is now CE-IVD certified.

PMA.core has many features. Below you can find a list of features that are now certified for clinical use or primary diagnosis:

Category Code Description
General requirementsURS-G-001Users have to login with a username and password
URS-G-004The software version can be consulted.
URS-G-005End-users can notify Pathomation if there is an issue with the software
URS-G-106The software must have a licensing scheme
URS-G-107Provide support for HTTPS communication (in addition to HTTP)
URS-G-108A webservice-based Application Programming Interface (API) is available
URS-G-2000A historical overview of license updates is available
URS-G-2001License management can be handled online without (physical nor virtual) server access
URS-G-2002Product owners are notified when the license expires
Storage mediaURS-SM-003Images can be added from multiple locations (paths)
URS-SM-2003Slides can be read from local server storage (hard disk)
URS-SM-2004Slides can be read from network drives (UNC paths)
URS-SM-2005Slides can be read from Amazon S3 compatible storage
URS-SM-3006Slides can be read from Azure blob storage
URS-SM-3007Slides can be read from Azure Data lakes (Gen2)
File format (brightfield)URS-FB-002Support the “3DHistech MRXS” file format (brightfield)
URS-FB-100Support the “Hamamatsu NDPI ” file format (brightfield)
URS-FB-101Support the “Aperio LEICA SVS” file format (brightfield)
URS-FB-102Support the “Aperio LEICA SCN” file format (brightield)
URS-FB-103Support the “Ventana Roche BIF” (with and without TIFP) file format (brightfield)
URS-FB-104Support the “Olympus VSI” file format (brightfield)
URS-FB-105Support the “Generic JPG ” file format (brightfield)
URS-FB-106Support the “Generic PNG” file format (brightfield)
URS-FB-200Support the “Generic TIFF” file format (brightfield)
URS-FB-201Support the “Zeiss ZVI” file format (brightfield)
URS-FB-202Support the “Zeiss CZI” file format (brightfield)
URS-FB-203Support the “Nikon ND2” file format (brightfield)
URS-FB-3000Support JPEG 2000 encoded slides (brightfield)
URS-FB-3002Support the “Sakura SVSLIDE” file format (brightfield)
URS-FB-3003Support the “Motic MDS” file format (brightfield)
URS-FB-3004Support the “Motic MDSX” file format (brightfield)
URS-FB-3007Support the “Olympus Webview” file format (brightfield)
URS-FB-3008Support the “Microsoft Deep Zoom .DZI” file format (brightfield)
URS-FB-3009Support the “Hamamatsu VMS” file format (brightfield)
URS-FB-3010Support the “Huron Technologies TIFF” file format (brightfield)
URS-FB-3011Support the “Aperio / Leica CWS” file format (brightfield)
URS-FB-3014Support the “Open Microscopy OME-TIFF” file format (brightfield)
URS-FB-3015Support the “Menarini DSight Raw INI” file format (brightfield)
URS-FB-3016Support the “Zoomify ZIF” file format (brightfield)
URS-FB-3017Support the “Smartzoom SZI” file format (brightfield)
URS-FB-3018Support the “Objective Imaging (Glissando)” file format (brightfield)
URS-FB-3020Support the “Unic Tech TMAP” file format (brightfield)
URS-FB-3021Support the “Jpeg XR JXR” file format (brightfield)
URS-FB-3022Support the “KFBio KFB” file format (brightfield)
URS-FB-3023Support the “GE Omnyx JP2” file format (brightfield)
URS-FB-3024Support the “GE Omnyx / Inspirata RTS” file format (brightfield)
URS-FB-3025Support the “Philips iSyntax” file format (brightfield)
URS-FB-3026Support the “Philips TIFF” file format (brightfield)
URS-FB-3027Support the “Omero ZARR” file format (brightfield)
File format (fluo)URS-FF-002Support the “3DHistech MRXS” file format (fluo)
URS-FF-100Support the “Hamamatsu NDPIS” file format (fluo)
URS-FF-101Support the “Aperio LEICA SVS” file format (fluo)
URS-FF-102Support the “Aperio LEICA SCN” file format (fluo)
URS-FF-104Support the “Olympus VSI” file format (fluo)
URS-FF-201Support the “Zeiss ZVI” file format (fluo)
URS-FF-202Support the “Zeiss CZI” file format (fluo)
URS-FF-203Support the “Nikon ND2” file format (fluo)
URS-FF-204Support the “Nikon TIFF” file format (fluo)
URS-FF-3005Support the “Aperio AFI” file format (fluo)
URS-FF-3012Support the “Leica LIF” file format (fluo)
URS-FF-3013Support the “Zeiss LSM” file format (fluo)
URS-FF-3014Support the “Open Microscopy OME-TIFF” file format (fluo)
URS-FF-3019Support the “Perkin Elmer QPTIFF” file format (fluo)
URS-FF-3028Support the “Olympus OIR” file format (fluo)
File format (z-stack)URS-FZ-002Support the “3DHistech MRXS” file format (z-stack)
URS-FZ-100Support the “Hamamatsu NDPIS” file format (z-stack)
URS-FZ-101Support the “Aperio LEICA SVS” file format (z-stack)
URS-FZ-102Support the “Aperio LEICA SCN” file format (z-stack)
URS-FZ-104Support the “Olympus VSI” file format (z-stack)
URS-FZ-201Support the “Zeiss ZVI” file format (z-stack)
URS-FZ-202Support the “Zeiss CZI” file format (z-stack)
URS-FZ-203Support the “Nikon ND2” file format (z-stack)
URS-FZ-3002Support the “Sakura SVSLIDE” file format (z-stack)
URS-FZ-3010Support the “Huron Technologies TIFF” file format (z-stack)
URS-FZ-3012Support the “Leica LIF” file format (z-stack)
URS-FZ-3013Support the “Zeiss LSM” file format (z-stack)
URS-FZ-3014Support the “Open Microscopy OME-TIFF” file format (z-stack)
URS-FZ-3018Support the “Objective Imaging (Glissando)” file format (z-stack)
URS-FZ-3028Support the “Olympus OIR” file format (z-stack)
CODEC encoding [FE]URS-FE-103Enable content streaming in both lossy (JPEG) and lossless (PNG) compressed file formats
URS-FE-2011Support JPEG encoding
URS-FE-2012Support JPEG-2000 encoding
URS-FE-2013Support JPEG-XR encoding
URS-FE-2014Support lossless JPEG compression
URS-FE-2015Support PNG encoding
Graphical annotations [N]URS-N-100Offer the option to store on-slide geometric annotations with slides
URS-N-2000Read / import “native” MRXS annotations
URS-N-2001Read / import “native” SVS annotations
URS-N-2002Read / import “third party” VIsiopharm MLD annotations
URS-N-2003Read / import “third party” Indica Labs HALO ANNOTATION annotations
URS-N-2004Read / import “third party” Definiens XML annotations
URS-N-2005Support the creation and management of WKT-formatted annotations
URS-N-2006Export annotations to WKT file format
URS-N-2007Export annotations to CSV file format
URS-N-2008Export annotations to MLD file format
URS-N-2009Export annotations to ANNOTATION file format
URS-N-2010Export annotations to (Aperio/Definiens) XML file format
Regulatory requirements [R]URS-R-001Data will be formatted to allow transfer to another system for long-term storage in a common portable format either during the life of the system or after the system is retired
URS-R-002The system will contain detection mechanisms for invalid field entries, values out of range, and blank fields if entry is required
URS-R-003It will be possible to provide regulatory agenties with both human-readable and electronic c opies of the records, including metadata. It will be possible to transfer data in a human readable format onto transportable media such as PDF, XML, SGML. The system must allow that the copying process produces copies that preserve the content and meaning of the records
URS-R-005The system will contain an automatically generated audit trail function for all process significant and GxP critical events and allow audit trails on tables and individual records
URS-R-006The audit trail data will be read-only
URS-R-007It will be impossible to disable the audit trail function
URS-R-008The system will prevent the accidental or intentional modifications or deletion of audit trail files
URS-R-009It will be possible to generate a report to view which data in the record has been modified
URS-R-010A mechanism will be in place to detect and report any attempts of unauthorized use immediately to the customer
URS-R-011The audit trail will record: user name, data and time (h/min/sec) of the event using local data and time of the host system, indication of the type of event: record creation/modification/deletion or approval, in case of modification/deletion: old value and new value, reason of change (if applicable)
URS-R-012A specific link must be in place to trace the audit trail data to the associated electronic record(s) itself
URS-R-013The system will not allow changes in date and time by the user
URS-R-014The system date and time will be periodically checked and corrected. The system will support time synchronization
URS-R-015The electronic audit trails will be readily available for review
URS-R-016The system will be protected against unauthorized use
URS-R-017Security will consist of at least two elements (e.g. login ID and password) in case of non-biometric security
URS-R-018The system must enforce and automatic log-out after a defined period of no activity
URS-R-019The system will allow the specification of different levels of access (e.g. user, administrator)
URS-R-020The system will detect security violations and produce an alarm or warning message
URS-R-021Controls will be in place to ensure that no two (2) individuals can have the same combination of identification code and password
URS-R-022If a password is not issued privately (i.e. the password issuer knows the password), the user will immediately reset their password
Documentation requirementsURS-D-001A user guide (manual) is available
URS-D-100User requirements are available
URS-D-101Installation manual is available
URS-D-2001Back-end programming (API) documentation is available
URS-D-2002Front-end programming (PMA.UI / JavaScript) documentation is available
Requirements (non-specific)URS-001It’s possible to view slides through the slide management module.
URS-003It’s possible to add users.
URS-004Only administrator users have access to the slide management module.
URS-005An undeletable administrator account is configured
URS-006The following user information can be recorded: first name, last name, login name, password and e-mail.
URS-007Users that are created in the slide management module get access to the viewing module.
URS-008Users can be given administrator rights.
URS-009Users can be suspended. As long as users are suspended, they do not have access to the software.
URS-010Raw server log files can be consulted by administrators (read only).
URS-011A list of users currently logged in (active session) is available. Active sessions can be terminated.
URS-012Users can quickly access the user manual
URS-013Users can log out
URS-101Offer the option to store form-based annotations with slides
URS-102Present a report with operating characteristics to assist in on-site installation troubleshooting
URS-3000Form template definitions can be imported and exported
URS-3001Users can be granted or denied access to specific directories
APIURS-A-250Method to identify the version / revision of PMA.core running
URS-A-251Method(s) to request licensing information from a distance
URS-A-252Method to authenticate users and generate sessionID variables
URS-A-253Method to de-authenticate an active sessionID
URS-A-254Method to determine whether a user can make annotations
URS-A-255Method to retrieve root-directories
URS-A-256Method to check if the server is responsive. Typically this is done through a server “ping”, but in productions environments this service is often disabled to prevent opportunistic phishing attempts.
URS-A-257Method to get an overview of all available root-directories.
URS-A-258Method to retrieve sub-directories from a parent directory
URS-A-259Method to retrieve hosted slides in a specific directory
URS-A-260Method to retrieve an anonymized string identification sequence representing a hosted slide
URS-A-261Method to retrieve information about a hosted slide
URS-A-262Methods to retrieve on-slide annotations
URS-A-263Methods to manipulate on-slide annotations
URS-A-264Method to obtain an on-slide annotation’s circumference (distance for 1D-objects)
URS-A-265Method to obtain an on-slide annotation’s surface (only for 2D-objects)
URS-A-266Method to query available form templates
URS-A-267Methods to retrieve slide-associated filled-out forms
URS-A-268Methods to manipulate slide-associated form data
URS-A-269Method(s) to change user passwords
URS-A-270Method to map a UID back to its real path reference
URS-A-271Method to map a root-directory virtual path to its physical presence on the hard disk
URS-A-350Method to obtain a unique identifier of a slide based on its contents
URS-A-351Method to search for slides
URS-A-352Method to create directories that requires administrator privileges
URS-A-353Method to delete directories that requires administrator privileges
URS-A-354Method to create users that requires administrator privileges
URS-A-355Method to move slides that requires administrator privileges
URS-A-356Method to rename slides that requires administrator privileges
URS-A-357Method to rename directories that requires administrator privileges
URS-A-358Method to export annotations in Visiopharm MLD, Halo XML and Well Known Text formats
URS-A-359Method to reset a user’s password
URS-A-360Method to remind a user’s password
URS-A-361Method to list all users that requires administrator privileges
URS-A-362Method to suspend a user that requires administrator privileges
URS-A-363Method to obtain user information for a session ID that requires administrator privileges
URS-A-2000Methods to programmatically (and transaction-based) upload a slide
URS-A-2002Methods to programmatically (and transaction-based) download a slide
PMA.UI frameworkURS-U-200A javascript viewport for whole slide images (WSI) is offered
URS-U-201A javascript gallery control for whole slide images (WSI) is offered
URS-U-202A javascript treeview control for whole slide images (WSI) is offered
URS-U-210The viewport retrieves tiles from PMA.core as needed
URS-U-300The viewport offers a configurable overview widget
URS-U-301The viewport offers a configurable dimensions control widget
URS-U-302The viewport offers a configurable barcode widget
URS-U-303The viewport offers a configurable rotation widget
URS-U-304The viewport offers a configurable filename widget
URS-U-305The viewport offers a configurable scalebar widget
URS-U-306The viewport offers a configurable scapshot button widget
URS-U-307The viewport offers a configurable color adjustment widget
URS-U-308The viewport offers a configurable zoom slider widget
URS-U-309The viewport offers configurable themes (layout)
URS-U-310The viewport offers configurable digital zoom levels
URS-U-320The viewport offers realtime distance measurements
URS-U-321The viewport offers realtime area measurements
URS-U-322Realtime measurements can handle dimensionless (no ppm indication) image data
URS-U-340The gallery control can toggle between thumbnail and label view
URS-U-341The gallery control offers “lazy loading”
URS-U-342The gallery control retrieves image data at the correct resolution (no client-side rescaling implied)
URS-U-360The tree control offers “lazy loading”
URS-U-380Make rectangular annotations
URS-U-381Make eliptical annotations
URS-U-382Make freehand annotations
URS-U-383Make landmark annotations
URS-U-384Make polygon annotations
URS-U-385Erase parts of an annotation
URS-U-386Change the style of an annotation (line, fill, opacity)
URS-U-387Make line annotations

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