Last synced on 11 July 2025 at 11:06 pm

Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device

Page Type
Product Code
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.
Physical State
An AC-powered or battery-powered device containing OCT hardware (optics and electronics), software and firmware for capturing images. Analysis algorithms are included as part of software.
Technical Method
The device allows the user to capture optical coherence tomography images of the eye. Using automated image analysis algorithms, the device provides additional analysis to segment and quantify regions or features of interest for the physician to interpret.
Target Area
Eye
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
886.1600
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code SAX is linked to regulation 21CFR886.1600, which does not seem to exist yet. It may be pending at the moment.

Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device

Page Type
Product Code
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.
Physical State
An AC-powered or battery-powered device containing OCT hardware (optics and electronics), software and firmware for capturing images. Analysis algorithms are included as part of software.
Technical Method
The device allows the user to capture optical coherence tomography images of the eye. Using automated image analysis algorithms, the device provides additional analysis to segment and quantify regions or features of interest for the physician to interpret.
Target Area
Eye
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
886.1600
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code SAX is linked to regulation 21CFR886.1600, which does not seem to exist yet. It may be pending at the moment.