The following data is part of a premarket notification filed by Imix Adr Finland Oy with the FDA for Panorad, Panorad Sl.
| Device ID | K113855 |
| 510k Number | K113855 |
| Device Name: | PANORAD, PANORAD SL |
| Classification | System, X-ray, Stationary |
| Applicant | IMIX ADR FINLAND OY 8870 RAVELLO CT Naples, FL 34114 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm IMIX ADR FINLAND OY 8870 RAVELLO CT Naples, FL 34114 |
| Product Code | KPR |
| Subsequent Product Code | LLZ |
| Subsequent Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-29 |
| Decision Date | 2012-01-25 |
| Summary: | summary |