The following data is part of a premarket notification filed by Swissray International, Inc. with the FDA for Ddrcombi Trauma.
| Device ID | K050718 |
| 510k Number | K050718 |
| Device Name: | DDRCOMBI TRAUMA |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | SWISSRAY INTERNATIONAL, INC. 1180 MCLESTER STREET Elizabeth, NJ 07201 |
| Contact | John Monahan |
| Correspondent | John Monahan SWISSRAY INTERNATIONAL, INC. 1180 MCLESTER STREET Elizabeth, NJ 07201 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-21 |
| Decision Date | 2005-05-26 |