The following data is part of a premarket notification filed by Sedecal Sa with the FDA for Sedecal Digital Radiographic Upgrade Model Sdru-t.
| Device ID | K130883 |
| 510k Number | K130883 |
| Device Name: | SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | SEDECAL SA C/PELAYA, 9-13, POL. IND. RIO DE JANEIRO Algete, Madrid, ES 28110 |
| Contact | Luisa Gomez De Aguero |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-03-29 |
| Decision Date | 2013-04-18 |
| Summary: | summary |