Ophthalmic · De Novo · 2024
Notal Vision Home Optical Coherence Tomography (OCT) System
Notal Vision Inc. Granted by FDA on 15 May 2024 under submission DEN230043, product code SAX (home monitoring ophthalmic optical coherence tomography (oct) imaging device). What FDA's record says, in FDA's words.
Device record · DEN230043
- Device. Notal Vision Home Optical Coherence Tomography (OCT) SystemDEVICE
- Company. Notal Vision IncCOMPANY
- Decision. 15 May 2024, De NovoDECISION
- Panel. OphthalmicPANEL
- Product code. SAX, Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging DeviceCODE
- Regulation. 21 CFR 886.1600, Class IIREG
- Source. FDA database entry · decision document (25 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA granted it for
The Indications for Use statement, verbatim, from the decision document.
The Notal Vision Home Optical Coherence Tomography (OCT) System is indicated as follows: 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.
The product code's definition, from FDA's classification record. 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.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsmeasurement or quantification
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code SAX. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
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