The following data is part of a premarket notification filed by Agfa Healthcare N.v. with the FDA for Impax Volume Viewing.
| Device ID | K111638 |
| 510k Number | K111638 |
| Device Name: | IMPAX VOLUME VIEWING |
| Classification | System, Image Processing, Radiological |
| Applicant | AGFA HEALTHCARE N.V. SEPTESTRAAT 27 Mortsel, BE B 2640 |
| Contact | Koen Cobbaert |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-06-13 |
| Decision Date | 2011-06-24 |
| Summary: | summary |