Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device
A home monitoring ophthalmic optical coherence tomography (OCT) imaging device is a prescription self-imaging device incorporating imaging hardware and automated image processing, enabling patients to perform OCT imaging at home so that a physician can remotely monitor ophthalmic diseases or conditions between scheduled clinical assessments. It is classified as FDA Class II (510(k) required) under regulation 886.1600 in the Ophthalmic specialty, with product code SAX. The device is not an implant and does not support life-sustaining functions.
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Basic Information
- Product Code
- SAX
- Device Class
- FDA class 2
- Regulation Number
- 886.1600
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN230043 | Notal Vision Home Optical Coherence Tomography (OCT) System | May 15, 2024 | Unknown | Notal Vision, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.