← FDA Medical Device Classifications
System, Imaging, Optical Coherence Tomography (Oct)
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
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown