The following data is part of a premarket notification filed by Agfa Corporation with the FDA for Computed Radiography System With Nx 1.0 Workstation.
| Device ID | K053634 |
| 510k Number | K053634 |
| Device Name: | COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | AGFA CORPORATION 10 SOUTH ACADEMY ST. Greenville, SC 29601 |
| Contact | Jeffery A Jedlicka |
| Correspondent | Jeffery A Jedlicka AGFA CORPORATION 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 | 2005-12-29 |
| Decision Date | 2006-01-17 |
| Summary: | summary |