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FDA 510(k)

Dynamika

K-Number: K161601 · 2017-05-17

ApplicantImage Analysis Limited
Decision Date2017-05-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Dynamika is a medical device manufactured by Image Analysis Limited. It received FDA 510(k) clearance on 2017-05-17 under approval number K161601. 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 Dynamika?

Dynamika is a medical device that received FDA 510(k) clearance on 2017-05-17. It is manufactured by Image Analysis Limited. The 510(k) number is K161601.

When was Dynamika approved by the FDA?

Dynamika received FDA 510(k) clearance on 2017-05-17, under approval number K161601.

What company makes Dynamika?

Dynamika is manufactured by Image Analysis Limited.

What is the FDA product code for Dynamika?

The FDA product code for Dynamika is LLZ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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