The following data is part of a premarket notification filed by Agfa Healthcare N.v. with the FDA for Impax Volume Viewing 4.0.
| Device ID | K161061 |
| 510k Number | K161061 |
| Device Name: | IMPAX Volume Viewing 4.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | AGFA HEALTHCARE N.V. SEPTESTRAAT 27 Mortsel, BE B-2640 |
| Contact | Koen Cobbaert |
| Correspondent | Shaeann Cavanagh AGFA HEALTHCARE CORPORATION 10 SOUTH ACADEMY STREET Greenville, SC 29601 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-15 |
| Decision Date | 2016-06-22 |
| Summary: | summary |