SAX · Class II · 21 CFR 886.1600

FDA Product Code SAX: Home Monitoring Ophthalmic Optical Coherence Tomography (oct) Imaging Device

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.

Leading manufacturers include Notal Vision, Inc..

1
Total
0
Cleared
343d
Avg days
2024
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Home Monitoring Ophthalmic Optical Coherence Tomography (oct) Imaging Device Devices (Product Code SAX)

1 devices
1–1 of 1
Not Cleared May 15, 2024
Notal Vision Home Optical Coherence Tomography (OCT) System
DEN230043
Notal Vision, Inc.
Ophthalmic · 343d

About Product Code SAX - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code SAX since 2024, with 0 receiving FDA clearance (average review time: 343 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

SAX devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →