Notal Vision Home Optical Coherence Tomography (OCT) System
Notal Vision Inc is listed for Notal Vision Home Optical Coherence Tomography (OCT) System (DEN230043). The FDA list gives May 15, 2024 as the date of the final decision. The lead panel is Ophthalmic, and the database link on the FDA list is the De Novo pathway. openFDA describes product code SAX as “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. openFDA records this submission’s decision description as “Unknown.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230043
- Date of final decision
- May 15, 2024
- Company on the FDA list
- Notal Vision Inc
- Lead panel
- Ophthalmic
- Primary product code
- SAX
- openFDA device name for the code
- Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device
- Device class
- 2
- Regulation number
- 886.1600
- openFDA decision description
- Unknown
- openFDA decision code
- DENG
- Statement or summary label
- Not returned
Product-code text from openFDA
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.