DR 800 with Tomosynthesis
K-Number: K183275 · 2019-02-01
ApplicantAgfa N.V.
Decision Date2019-02-01
Product CodeIZF
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
DR 800 with Tomosynthesis is a medical device manufactured by Agfa N.V.. It received FDA 510(k) clearance on 2019-02-01 under approval number K183275. The device is classified under product code IZF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DR 800 with Tomosynthesis?
DR 800 with Tomosynthesis is a medical device that received FDA 510(k) clearance on 2019-02-01. It is manufactured by Agfa N.V.. The 510(k) number is K183275.
When was DR 800 with Tomosynthesis approved by the FDA?
DR 800 with Tomosynthesis received FDA 510(k) clearance on 2019-02-01, under approval number K183275.
What company makes DR 800 with Tomosynthesis?
DR 800 with Tomosynthesis is manufactured by Agfa N.V..
What is the FDA product code for DR 800 with Tomosynthesis?
The FDA product code for DR 800 with Tomosynthesis is IZF.
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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.