The following data is part of a premarket notification filed by Apixia Inc. with the FDA for Apixia Digirex Digital Dental Rediography System.
| Device ID | K120106 |
| 510k Number | K120106 |
| Device Name: | APIXIA DIGIREX DIGITAL DENTAL REDIOGRAPHY SYSTEM |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | APIXIA INC. 18688 SAN JOSE AVE. Industry, CA 91748 |
| Contact | Eric Huang |
| Correspondent | Eric Huang APIXIA INC. 18688 SAN JOSE AVE. Industry, CA 91748 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-13 |
| Decision Date | 2012-05-07 |