Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1600](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1600) → SAX — Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device

# SAX · Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device

_Ophthalmic · 21 CFR 886.1600 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/SAX

## Overview

- **Product Code:** SAX
- **Device Name:** Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device
- **Regulation:** [21 CFR 886.1600](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1600)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

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. The Notal Vision Home Optical Coherence Tomography (OCT) System is an 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), providing segmentation and estimation of the volume of these spaces.

## Classification Rationale

Class II (special controls). The device is granted under the De Novo process, with risks mitigated by general controls and the identified special controls.

## Special Controls

In combination with the general controls of the FD&C Act, the home monitoring ophthalmic imaging device is subject to the following special controls:

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN230043](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/SAX/DEN230043.md) | Notal Vision Home Optical Coherence Tomography (OCT) System | Notal Vision, Inc. | May 15, 2024 | DENG |

## Top Applicants

- Notal Vision, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/SAX](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/SAX)

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