Software, digital imaging, pathology

Primary use
Diagnosis / Measurement / Monitoring
Type of medical device or related product
Software
General vs. specific use (health condition)
General
Intended population sex
All
Level of technical knowledge
Specialized clinical
Capital
Yes
Reusable
Yes
Requirements
None
WHO list of priority medical devices
Cancer management (2017)
Service delivery platforms / Healthcare levels
Second-level and third-level hospital services and specialized outpatient services
Healthcare unit
Laboratory
EMDN related code(s)
Z12040182
GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES
The code(s) and term(s) in this section were observed and retrieved from public databases and have not been validated by health regulatory authorities. Please consult your regulatory agency and EMDN site: https://webgate.ec.europa.eu/dyna2/emdn
GMDN related code(s)
58721
Histology/cytology/microbiology image-analysis interpretive software IVD (An in vitro diagnostic interpretive software program with image analysis algorithms [e.g., artificial intelligence (AI)-based] intended to be used in a digital pathology or microbiology laboratory to assist in the analysis of clinical specimens (e.g., biopsy, blood smear, urine) and/or microbial cultures for the quantitative/qualitative detection of cell markers (e.g., hormone receptors), changes in tissue architecture and/or cell morphology/physiology [e.g., nucleus size, cytoplasmic granularity, rate of cell division], and/or infectious microorganisms associated with a disease (e.g., breast cancer, malaria, UTI). Results are also interpreted by a clinician to guide patient management.)
The medical device term(s), code(s) and definition(s) in this section were retrieved from databases external to WHO. As there might be more than one name, definition and “Nomenclature Code” related to the specific medical device, please consult https://gmdnagency.org GMDN ®. © GMDN Agency 2005-2025 
WHO related resources
Decommissioning
WHO resources on medical devices