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 |