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FDA 510(k)

ArteraAI Breast

K-Number: K254115 · 2026-05-04

ApplicantArtera, Inc.
Decision Date2026-05-04
Product CodeSHW
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

ArteraAI Breast is a medical device manufactured by Artera, Inc.. It received FDA 510(k) clearance on 2026-05-04 under approval number K254115. The device is classified under product code SHW. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ArteraAI Breast?

ArteraAI Breast is a medical device that received FDA 510(k) clearance on 2026-05-04. It is manufactured by Artera, Inc.. The 510(k) number is K254115.

When was ArteraAI Breast approved by the FDA?

ArteraAI Breast received FDA 510(k) clearance on 2026-05-04, under approval number K254115.

What company makes ArteraAI Breast?

ArteraAI Breast is manufactured by Artera, Inc..

What is the FDA product code for ArteraAI Breast?

The FDA product code for ArteraAI Breast is SHW.

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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