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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 the device name listed in this FDA 510(k) record. The listed applicant is Arterys, Inc.. It received FDA 510(k) clearance on 2016-10-28 under 510(k) 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. The listed applicant is Arterys, Inc.. The 510(k) number is K162513.

When did Arterys Software v2.0 receive FDA 510(k) clearance?

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

Who is the listed applicant for Arterys Software v2.0?

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

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

The FDA product code for Arterys Software v2.0 is LLZ.

Other records listing Arterys, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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