The following data is part of a premarket notification filed by Agfa Corp. with the FDA for Dx-si.
| Device ID | K063421 |
| 510k Number | K063421 |
| Device Name: | DX-SI |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | AGFA CORP. 10 SOUTH ACADEMY ST. Greenville, SC 29601 |
| Contact | Jeffery A Jedlicka |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-11-13 |
| Decision Date | 2006-11-22 |
| Summary: | summary |