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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2019-04-25 under 510(k) 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. The listed applicant is Brainlab AG. The 510(k) number is K190042.

When did Brainlab Elements Image Fusion Angio receive FDA 510(k) clearance?

Brainlab Elements Image Fusion Angio received FDA 510(k) clearance on 2019-04-25, under 510(k) number K190042.

Who is the listed applicant for Brainlab Elements Image Fusion Angio?

The FDA 510(k) record lists Brainlab AG as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: 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.

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