# DEN230043: Notal Vision Home Optical Coherence Tomography (OCT) System

- Pathway: De Novo (Direct)
- Applicant: Notal Vision, Inc.
- Decided: May 15, 2024 after 343 days
- Product code: SAX (Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device)
- Device class: 2
- Regulation: 21 CFR 886.1600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The Notal Vision Home Optical Coherence Tomography (OCT) System is an Artificial Intelligence (AI)-based Home Use device indicated for visualization of intraretinal and subretinal hypo-reflective spaces in a 10 by 10-degrees area centered on the point of fixation of eyes diagnosed with neovascular age-related macular degeneration (NV-AMD). In addition, it provides segmentation and an estimation of the volume of hypo-reflective spaces. The Notal Home OCT device is intended for imaging at home between regularly scheduled clinic assessments and not intended to be used to make treatment decisions or replace standard-of care regularly scheduled examinations and clinical testing as needed, including in-office imaging and assessments for changes in vision, by an ophthalmologist.

Source page: https://510kreport.com/device/DEN230043
Methodology: https://510kreport.com/methodology