Documento fuente o registro público

FDA 510(k) K254115 — ArteraAI Breast

FDA 510(k) index record K254115. Device: ArteraAI Breast. Applicant as listed: Artera, Inc.. Decision date: 2026-05-04.

OtherU.S. Food and Drug Administration (FDA)2026-05-04

Fuente

"device_name": "ArteraAI Breast"
api.fda.gov · Consultado el 2026-10-22

Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.

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Reviewer

Automated FDA record verification

Published

2026-10-20

Updated

2026-10-23

Disclaimer

professional use

References

FDA 510(k) public index record K254115.

Device name: ArteraAI Breast. Applicant as listed: Artera, Inc..

Decision date: 2026-05-04. Decision wording: Substantially Equivalent.

Product code: SHW. Regulation: 21 CFR 864.3755. Medical specialty: Pathology.

This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.

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FDA 510(k) K254115 — ArteraAI Breast

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