The following data is part of a premarket notification filed by Imix Adr Finland Oy with the FDA for Imix 2000 Digital Radiography System, Models Unv 3k, Unv 3kw, Unv 4k.
| Device ID | K072867 |
| 510k Number | K072867 |
| Device Name: | IMIX 2000 DIGITAL RADIOGRAPHY SYSTEM, MODELS UNV 3K, UNV 3KW, UNV 4K |
| Classification | System, X-ray, Stationary |
| Applicant | IMIX ADR FINLAND OY 75 ORCHARD SPRING ESTS Waterbury, VT 05676 |
| Contact | James Taylor |
| Correspondent | James Taylor IMIX ADR FINLAND OY 75 ORCHARD SPRING ESTS Waterbury, VT 05676 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-05 |
| Decision Date | 2007-11-21 |