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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 the device name listed in this FDA 510(k) record. The listed applicant is Arterys, Inc.. It received FDA 510(k) clearance on 2018-01-25 under 510(k) 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. The listed applicant is Arterys, Inc.. The 510(k) number is K173542.

When did Arterys Oncology DL receive FDA 510(k) clearance?

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

Who is the listed applicant for Arterys Oncology DL?

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 Oncology DL?

The FDA product code for Arterys Oncology DL 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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