The following data is part of a premarket notification filed by Agfa Healthcare N.v. with the FDA for Dr 800 With Musica Dynamic.
| Device ID | K180589 |
| 510k Number | K180589 |
| Device Name: | DR 800 With MUSICA Dynamic |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | Agfa HealthCare N.V. Septestraat 27 Mortsel, BE B-2640 |
| Contact | Wim Govaerts |
| Correspondent | Shaeann Cavanagh Agfa HealthCare Corporation 10 South Academy Street Greenville, SC 29601 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-06 |
| Decision Date | 2018-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414904251805 | K180589 | 000 |
| 05414904233320 | K180589 | 000 |