DEN230043 is an FDA 510(k) submission for the Notal Vision Home Optical Coherence Tomography (OCT) System. This device is classified as a Home Monitoring Ophthalmic Optical Coherence Tomography (oct) Imaging Device (Class II - Special Controls, product code SAX).
Submitted by Notal Vision, Inc. (Manassas, US). The FDA issued a Not Cleared (DENG) decision on May 15, 2024.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1600. 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..
| 510(k) Number | DEN230043 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | June 07, 2023 |
| Decision Date | May 15, 2024 |
| Days to Decision | 343 days |
| Submission Type | Direct |
| Review Panel | Ophthalmic (OP) |
| Summary | - |
| Product Code | SAX - Home Monitoring Ophthalmic Optical Coherence Tomography (oct) Imaging Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1600 |
| Definition | 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. |