Brainlab Elements Image Fusion Angio
K-Number: K190042 · 2019-04-25
ApplicantBrainlab AG
Decision Date2019-04-25
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Brainlab Elements Image Fusion Angio is a medical device manufactured by Brainlab AG. It received FDA 510(k) clearance on 2019-04-25 under approval number K190042. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Brainlab Elements Image Fusion Angio?
Brainlab Elements Image Fusion Angio is a medical device that received FDA 510(k) clearance on 2019-04-25. It is manufactured by Brainlab AG. The 510(k) number is K190042.
When was Brainlab Elements Image Fusion Angio approved by the FDA?
Brainlab Elements Image Fusion Angio received FDA 510(k) clearance on 2019-04-25, under approval number K190042.
What company makes Brainlab Elements Image Fusion Angio?
Brainlab Elements Image Fusion Angio is manufactured by Brainlab AG.
What is the FDA product code for Brainlab Elements Image Fusion Angio?
The FDA product code for Brainlab Elements Image Fusion Angio is LLZ.
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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.