FDA 510(k)

Arterys Viewer

K-Number: K171544 · 2017-07-18

Decision Date2017-07-18

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Arterys Viewer is the device name listed in this FDA 510(k) record. The listed applicant is Arterys, Inc.. It received FDA 510(k) clearance on 2017-07-18 under 510(k) number K171544. 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 Viewer?

Arterys Viewer is a medical device that received FDA 510(k) clearance on 2017-07-18. The listed applicant is Arterys, Inc.. The 510(k) number is K171544.

When did Arterys Viewer receive FDA 510(k) clearance?

Arterys Viewer received FDA 510(k) clearance on 2017-07-18, under 510(k) number K171544.

Who is the listed applicant for Arterys Viewer?

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 Viewer?

The FDA product code for Arterys Viewer 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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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.