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System, Imaging, Optical Coherence Tomography (Oct)

System, Imaging, Optical Coherence Tomography (Oct) is a medical device type in the Radiology 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.

Global Registration Data
Multi-Country Intelligence
System, Imaging, Optical Coherence Tomography (Oct)
Radiology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

NQQ

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Class 2

21 CFR 892.1560

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Radiology

Device Characteristics

No

No

No

Eligible

Definition

This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.