OCT影像系統搭配AI/ML軟體，用於輔助偵測乳癌
PMA 核准號：P250008 · 2026-08-10
廣告
決定日期2026-08-10
PMA 編號P250008
產品代碼SHH
器械分類3 類
醫療專科U
諮詢委員會SU
請提供完整的描述文本，以便我進行翻譯。
器材摘要
OCT imaging system with AI/ML software for adjunctive detection of breast cancer is the device name listed in this FDA 510(k) record. The listed applicant is Perimeter Medical Imaging Ai, Inc.. It received FDA 510(k) clearance on 2026-08-10. The device is classified under product code SHH. It was reviewed by the SU advisory panel.
常見問題
What is the OCT imaging system with AI/ML software for adjunctive detection of breast cancer?
OCT imaging system with AI/ML software for adjunctive detection of breast cancer is a medical device that received FDA 510(k) clearance on 2026-08-10. The listed applicant is Perimeter Medical Imaging Ai, Inc..
When did OCT imaging system with AI/ML software for adjunctive detection of breast cancer receive FDA 510(k) clearance?
The clearance date for OCT imaging system with AI/ML software for adjunctive detection of breast cancer can be found in the official FDA records.
Who is the listed applicant for OCT imaging system with AI/ML software for adjunctive detection of breast cancer?
The FDA 510(k) record lists Perimeter Medical Imaging Ai, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OCT imaging system with AI/ML software for adjunctive detection of breast cancer?
The FDA product code for OCT imaging system with AI/ML software for adjunctive detection of breast cancer is SHH.
相關臨床試驗
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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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