The following data is part of a premarket notification filed by Sedecal S.a. with the FDA for Definium 5000 X-ray System.
| Device ID | K063283 |
| 510k Number | K063283 |
| Device Name: | DEFINIUM 5000 X-RAY SYSTEM |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | SEDECAL S.A. PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm SEDECAL S.A. PO BOX 7007 Deerfield, IL 60015 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-30 |
| Decision Date | 2006-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682104364 | K063283 | 000 |