Ophthalmology
Notal Vision Home Optical Coherence Tomography (OCT) System
Notal Vision Inc
A home monitoring ophthalmic imaging device is a prescription self-imaging device that incorporates imaging system hardware and automated image processing and analysis to enable patients at home to provide measurements that are intended for use by a physician for monitoring ophthalmic diseases or conditions in between regularly scheduled assessments.
FDA Submission Metadata
- Submission number
- DEN230043
- Decision date
- May 2024
- FDA panel
- Ophthalmic
- Product code
- SAX
- Clinical task (npj)
- quantification/feature localization
- Data modality (npj)
- Images
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
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