# System, Imaging, Optical Coherence Tomography (Oct)
> **Product code: NQQ** · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.1560
## Classification
- **FDA Product Code:** NQQ
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 892.1560
- **Review panel:** SU
- **Medical specialty:** Radiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## Definition

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

## Market data
- **Cleared 510(k) submissions:** 46
- **Registered establishments:** 27
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NQQ)
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