ArteraAI 乳癌
K 號：K254115 · 2026-05-04
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器材摘要
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.
常見問題
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.
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相關器械（代碼：SHW）
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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