Data / Medical devices / United States / Genoray America Inc.
Genoray America Inc.: FDA-registered device maker in Anaheim, CA, United States, 3 510(k) clearances
Genoray America Inc. is registered with the FDA (registration 3007538876) in Anaheim, CA, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 10, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007538876
- Address
- 1220 N Simon Circle Unit B, Anaheim, CA, United States, 92806
- Owner or operator
- Genoray America Inc. (10029239)
- Roles
- Complaint file establishment, Repackager or relabeler
- First device listed
- November 12, 2013
- Registered through
- 2026
- Brand names listed
- PAPAYA 3D Plus, PAPAYA Plus
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, X-Ray, Extraoral Source, Digital | MUH | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| X-Ray, Tomography, Computed, Dental | OAS | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| December 10, 2015 | K150354 | PAPAYA 3D Plus | OAS | Substantially Equivalent | Genoray Co., Ltd. | accessdata.fda.gov |
| October 31, 2014 | K141700 | PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM | MUH | Substantially Equivalent | Genoray Co., Ltd. | accessdata.fda.gov |
| November 6, 2013 | K130419 | PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM | MUH | Substantially Equivalent | Genoray Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Extraoral Source, Digital
- All makers of X-Ray, Tomography, Computed, Dental
Updated December 10, 2015. 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.