DR 800 with MUSICA Dynamic
FDA 510(k) K180589 · Agfa Healthcare N.V.
510(k) numberK180589
Submission
- Device name
- DR 800 with MUSICA Dynamic
- Applicant
- Agfa Healthcare N.V.
Mortsel, BE - Received
- March 6, 2018
- Decision date
- April 5, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was DR 800 with MUSICA Dynamic cleared by the FDA?
DR 800 with MUSICA Dynamic (K180589) received a 510(k) decision of Substantially Equivalent on April 5, 2018, 30 days after the submission was received.
What is the product code of K180589?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.