The following data is part of a premarket notification filed by Agfa Healthcare Corporation with the FDA for Agfa Computed Radiography Systems With Nx2008 Workstations.
| Device ID | K081963 |
| 510k Number | K081963 |
| Device Name: | AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | AGFA HEALTHCARE CORPORATION 10 SOUTH ACADEMY STREET Greenville, SC 29601 |
| Contact | Jeffery A Jedlicka |
| 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 | 2008-07-10 |
| Decision Date | 2008-07-25 |
| Summary: | summary |