DR 800 with MUSICA Dynamic
K-Number: K180589 · 2018-04-05
ApplicantAgfa Healthcare N.V.
Decision Date2018-04-05
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
DR 800 with MUSICA Dynamic is a medical device manufactured by Agfa Healthcare N.V.. It received FDA 510(k) clearance on 2018-04-05 under approval number K180589. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DR 800 with MUSICA Dynamic?
DR 800 with MUSICA Dynamic is a medical device that received FDA 510(k) clearance on 2018-04-05. It is manufactured by Agfa Healthcare N.V.. The 510(k) number is K180589.
When was DR 800 with MUSICA Dynamic approved by the FDA?
DR 800 with MUSICA Dynamic received FDA 510(k) clearance on 2018-04-05, under approval number K180589.
What company makes DR 800 with MUSICA Dynamic?
DR 800 with MUSICA Dynamic is manufactured by Agfa Healthcare N.V..
What is the FDA product code for DR 800 with MUSICA Dynamic?
The FDA product code for DR 800 with MUSICA Dynamic is JAA.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.