The following data is part of a premarket notification filed by Fona Srl with the FDA for Fona Pan/ceph.
| Device ID | K161131 |
| 510k Number | K161131 |
| Device Name: | FONA Pan/Ceph |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | FONA SRL VIA GALILEO GALILEI 11 Assago, IT 20090 |
| Contact | Elisa Gusberti |
| Correspondent | Elisa Gusberti FONA SRL VIA GALILEO GALILEI 11 Assago, IT 20090 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-21 |
| Decision Date | 2016-11-03 |
| Summary: | summary |