The following data is part of a premarket notification filed by Agfa Corp. with the FDA for Agfa Cr50.0.
| Device ID | K050810 |
| 510k Number | K050810 |
| Device Name: | AGFA CR50.0 |
| 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 | Jeffery A Jedlicka AGFA CORP. 10 SOUTH ACADEMY ST. Greenville, SC 29601 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-31 |
| Decision Date | 2005-04-21 |
| Summary: | summary |