The following data is part of a premarket notification filed by Agfa Corp. with the FDA for Radiotherapy Solution Based On Cr.
| Device ID | K042779 |
| 510k Number | K042779 |
| Device Name: | RADIOTHERAPY SOLUTION BASED ON CR |
| Classification | System, Imaging, X-ray, Electrostatic |
| Applicant | AGFA CORP. 10 SOUTH ACADEMY ST. Greenville, SC 29601 |
| Contact | Jeffery A Jedlicka |
| Correspondent | William Sammons UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | IXK |
| CFR Regulation Number | 892.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-10-06 |
| Decision Date | 2004-10-21 |
| Summary: | summary |