The Claris CBCT Computed Tomography X-Ray System is a dedicated Xray imaging device that acquires a 360-degree rotational X-ray sequence of images for use as diagnostic support in radiology…
The Claris CBCT Computed Tomography X-Ray System is a dedicated Xray imaging device that acquires a 360-degree rotational X-ray sequence of images for use as diagnostic support in radiology of the dento-maxillo-facial complex and in the field of maxillofacial surgery.
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (1), Zhejiang (1).
Record
Regulatory record for Claris | Listed by | iCRco Inc., United States |
| FDA product code | OAS |
| Device type | X-Ray, Tomography, Computed, Dental |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1750 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K120753 |
| Record published | 2026-07-22 |
Specifications
Specifications | MRI safety | MR Unsafe |
| Prescription | Prescription only |
| Distribution end date | 2030-02-01 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.