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FDA 510(k)

Arterys Oncology DL

K-Number: K173542 · 2018-01-25

ApplicantArterys, Inc.
Decision Date2018-01-25
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Arterys Oncology DL is a medical device manufactured by Arterys, Inc.. It received FDA 510(k) clearance on 2018-01-25 under approval number K173542. 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 Oncology DL?

Arterys Oncology DL is a medical device that received FDA 510(k) clearance on 2018-01-25. It is manufactured by Arterys, Inc.. The 510(k) number is K173542.

When was Arterys Oncology DL approved by the FDA?

Arterys Oncology DL received FDA 510(k) clearance on 2018-01-25, under approval number K173542.

What company makes Arterys Oncology DL?

Arterys Oncology DL is manufactured by Arterys, Inc..

What is the FDA product code for Arterys Oncology DL?

The FDA product code for Arterys Oncology DL is LLZ.

Other Devices by Arterys, Inc.

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Related Devices (Code: LLZ)

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.