Software, Optical Coherence Tomography (OCT)

Primary use
Diagnosis / Measurement / Monitoring
Type of medical device or related product
Software
General vs. specific use (health condition)
Specific
Intended population sex
All
Level of technical knowledge
Specialized clinical
Capital
Yes
Reusable
Yes
Requirements
None
WHO list of priority medical devices
Eye care (2022)
Service delivery platforms / Healthcare levels
First-level (district) hospital services
Second-level and third-level hospital services and specialized outpatient services
Healthcare unit
Inpatient care
Outpatient care
Specialized diagnostics
EMDN related code(s)
Z12120192
OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE
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)
58713
Retinal image analysis software (A software program intended to analyse images of the retina to provide interpretive results for clinical decision support relating to retinal diseases (e.g., diabetic retinopathy, choroidal neovascularization). It utilizes specific algorithms and/or artificial intelligence (AI) and deep learning techniques to assess and perform interpretation of diagnostic images acquired by retinal imaging devices (e.g., fundus camera, retinal optical coherence tomography system, ophthalmoscope) for early diagnosis and management of patients at risk.)
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