The following data is part of a premarket notification filed by Agfa N.v. with the FDA for Dr 800 With Tomosynthesis.
| Device ID | K183275 |
| 510k Number | K183275 |
| Device Name: | DR 800 With Tomosynthesis |
| Classification | System, X-ray, Tomographic |
| Applicant | Agfa N.V. Septestraat 27 Mortsel, BE B-2640 |
| Contact | Wim Govaerts |
| Correspondent | Shaeann Cavanagh Agfa US Corp. 10 South Academy Street Greenville, SC 29601 |
| Product Code | IZF |
| CFR Regulation Number | 892.1740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-23 |
| Decision Date | 2019-02-01 |
| Summary: | summary |