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FDA 510(k)

Arterys MICA

K-Number: K182034 · 2018-10-17

ApplicantArterys, Inc.
Decision Date2018-10-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Arterys MICA is a medical device manufactured by Arterys, Inc.. It received FDA 510(k) clearance on 2018-10-17 under approval number K182034. 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 MICA?

Arterys MICA is a medical device that received FDA 510(k) clearance on 2018-10-17. It is manufactured by Arterys, Inc.. The 510(k) number is K182034.

When was Arterys MICA approved by the FDA?

Arterys MICA received FDA 510(k) clearance on 2018-10-17, under approval number K182034.

What company makes Arterys MICA?

Arterys MICA is manufactured by Arterys, Inc..

What is the FDA product code for Arterys MICA?

The FDA product code for Arterys MICA is LLZ.

Other Devices by Arterys, Inc.

K162513Arterys Software v2.0 K171544Arterys Viewer K163253Arterys Cardio DL 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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