Data / Medical devices / United States / Apixia Inc.
Apixia Inc.: FDA-registered device maker in City of Industry, CA, United States, 2 510(k) clearances
Apixia Inc. is registered with the FDA (registration 3008361230) in City of Industry, CA, United States. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 7, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008361230
- Address
- 18688 E. San Jose Ave, City of Industry, CA, United States, 91748
- Owner or operator
- APIXIA INC. (10031841)
- Roles
- Repackager or relabeler
- First device listed
- June 11, 2010
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aligner, Beam, X-Ray | EHA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Camera, Surgical And Accessories | KQM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Film, Radiographic | IWZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Holder, Film, X-Ray | EGZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| System, X-Ray, Extraoral Source, Digital | MUH | 2 | Repackager or relabeler | accessdata.fda.gov |
| Unit, Operative Dental, Accessories | NRD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Unit, X-Ray, Extraoral With Timer | EHD | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 7, 2012 | K120106 | APIXIA DIGIREX DIGITAL DENTAL REDIOGRAPHY SYSTEM | MUH | Substantially Equivalent | Apixia, Inc. | accessdata.fda.gov |
| April 24, 2006 | K060640 | DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM | EHD | Substantially Equivalent | Dentamerica | accessdata.fda.gov |
Compare with other makers
- All makers of Camera, Surgical And Accessories
- All makers of Aligner, Beam, X-Ray
- All makers of Film, Radiographic
- All makers of Unit, Operative Dental, Accessories
- All makers of Unit, X-Ray, Extraoral With Timer
- All makers of System, X-Ray, Extraoral Source, Digital
Updated May 7, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.