Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device
- US Product Code (FDA)
- SAXView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 886.1600View CFR Regulation →
- Medical specialty
- Ophthalmic
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
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.
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Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device is a medical device type in the Ophthalmic specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.