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FDA 510(k)

Arterys Software v2.0

K-Number: K162513 · 2016-10-28

ApplicantArterys, Inc.
Decision Date2016-10-28
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Arterys Software v2.0 is a medical device manufactured by Arterys, Inc.. It received FDA 510(k) clearance on 2016-10-28 under approval number K162513. 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 Arterys Software v2.0?

Arterys Software v2.0 is a medical device that received FDA 510(k) clearance on 2016-10-28. It is manufactured by Arterys, Inc.. The 510(k) number is K162513.

When was Arterys Software v2.0 approved by the FDA?

Arterys Software v2.0 received FDA 510(k) clearance on 2016-10-28, under approval number K162513.

What company makes Arterys Software v2.0?

Arterys Software v2.0 is manufactured by Arterys, Inc..

What is the FDA product code for Arterys Software v2.0?

The FDA product code for Arterys Software v2.0 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.

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