The following data is part of a premarket notification filed by Agfa Healthcare N.v. with the FDA for Enterprise Imaging Xero Viewer 8.1.
| Device ID | K170434 |
| 510k Number | K170434 |
| Device Name: | Enterprise Imaging XERO Viewer 8.1 |
| Classification | System, Image Processing, Radiological |
| Applicant | Agfa HealthCare N.V. Septestraat 27 Mortsel, BE B-2640 |
| Contact | Jodi Coleman |
| 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 | 2017-02-13 |
| Decision Date | 2017-07-03 |
| Summary: | summary |