The following data is part of a premarket notification filed by Del Medical, Inc. with the FDA for Delworks Dr System.
| Device ID | K140825 |
| 510k Number | K140825 |
| Device Name: | DELWORKS DR SYSTEM |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | DEL MEDICAL, INC. 8870 RAVELLO CT Naples, FL 34114 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm U.M.G. Inc. / Del Medical, Inc. 8870 RAVELLO CT Naples, FL 34114 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-01 |
| Decision Date | 2014-07-17 |
| Summary: | summary |