The following data is part of a premarket notification filed by Imix Adr Finland Oy with the FDA for Imix Insight X-ray Systems.
| Device ID | K073114 |
| 510k Number | K073114 |
| Device Name: | IMIX INSIGHT X-RAY SYSTEMS |
| Classification | System, X-ray, Stationary |
| Applicant | IMIX ADR FINLAND OY P.O. BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm IMIX ADR FINLAND OY P.O. BOX 7007 Deerfield, IL 60015 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-05 |
| Decision Date | 2008-01-17 |
| Summary: | summary |