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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 the device name listed in this FDA 510(k) record. The listed applicant is Artera, Inc.. It received FDA 510(k) clearance on 2026-05-04 under 510(k) 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. The listed applicant is Artera, Inc.. The 510(k) number is K254115.

When did ArteraAI Breast receive FDA 510(k) clearance?

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

Who is the listed applicant for ArteraAI Breast?

The FDA 510(k) record lists Artera, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ArteraAI Breast?

The FDA product code for ArteraAI Breast is SHW.

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.

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