FDA 510(k)

MammoScreen BD

K 號：K243685 · 2025-08-22

決定日期2025-08-22

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

MammoScreen BD is the device name listed in this FDA 510(k) record. The listed applicant is Therapixel. It received FDA 510(k) clearance on 2025-08-22 under 510(k) number K243685. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MammoScreen BD?

MammoScreen BD is a medical device that received FDA 510(k) clearance on 2025-08-22. The listed applicant is Therapixel. The 510(k) number is K243685.

When did MammoScreen BD receive FDA 510(k) clearance?

MammoScreen BD received FDA 510(k) clearance on 2025-08-22, under 510(k) number K243685.

Who is the listed applicant for MammoScreen BD?

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

What is the FDA product code for MammoScreen BD?

The FDA product code for MammoScreen BD is QIH.

其他以 Therapixel 為申請人之記錄

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。

K260714MammoScreen®（5）K243679MammoScreen®（4）K241561MammoScreen BD K240301MammoScreen®（3）K211541MammoScreen 2.0 K192854mammoScreen

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相關器械（代碼：QIH）

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。

K260055syngo.CT 脑量化Siemens Medical Solutions USA, Inc.K262390骨專家Visiana K261368快速平台（R6.7）Ischemaview, Inc.K261623EchoPAC 軟體僅 / EchoPAC 插件（v211）GE Medical Systems Ultrasound and Primary Care Diagnostics K261677人工智慧腎臟評估（AIRA）版本 1Aramis Global AI Consultancies, LLC K2608794DMINVIA, LLC

官方來源

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