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FDA 510(k)

Arterys Viewer

K-Number: K171544 · 2017-07-18

ApplicantArterys, Inc.
Decision Date2017-07-18
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Arterys Viewer is a medical device manufactured by Arterys, Inc.. It received FDA 510(k) clearance on 2017-07-18 under approval 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. It is manufactured by Arterys, Inc.. The 510(k) number is K171544.

When was Arterys Viewer approved by the FDA?

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

What company makes Arterys Viewer?

Arterys Viewer is manufactured by Arterys, Inc..

What is the FDA product code for Arterys Viewer?

The FDA product code for Arterys Viewer is LLZ.

Other Devices by Arterys, Inc.

K162513Arterys Software v2.0 K163253Arterys Cardio DL K182034Arterys MICA K173542Arterys Oncology DL K192437Arterys MICA K203744Arterys MICA

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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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