← FDA Medical Device Classifications
X-Ray, Tomography, Computed, Dental
OAS · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.1750
Classification
- FDA Product Code
OAS- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 892.1750
- Review panel
- RA
- Medical specialty
- Radiology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.
Market data
- Cleared 510(k) submissions
- 131
- Registered establishments
- 46
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown