The following data is part of a premarket notification filed by 3disc Americas with the FDA for Computed Raddiography Scanner.
| Device ID | K102619 |
| 510k Number | K102619 |
| Device Name: | COMPUTED RADDIOGRAPHY SCANNER |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | 3DISC AMERICAS 8870 RAVELLO CT Naples, FL 34114 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm 3DISC AMERICAS 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 | 2010-09-13 |
| Decision Date | 2011-05-13 |
| Summary: | summary |