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FDA 510(k)

ArmSure 閃光定位系統

K 號：K251992 · 2026-02-11

申請人Savfe Co. , Ltd.
決定日期2026-02-11
產品代碼OWB
諮詢委員會RA
決定相當於

器材摘要

ArmSure Fluoroscopic Positioning System is the device name listed in this FDA 510(k) record. The listed applicant is Savfe Co. , Ltd.. It received FDA 510(k) clearance on 2026-02-11 under 510(k) number K251992. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ArmSure Fluoroscopic Positioning System?

ArmSure Fluoroscopic Positioning System is a medical device that received FDA 510(k) clearance on 2026-02-11. The listed applicant is Savfe Co. , Ltd.. The 510(k) number is K251992.

When did ArmSure Fluoroscopic Positioning System receive FDA 510(k) clearance?

ArmSure Fluoroscopic Positioning System received FDA 510(k) clearance on 2026-02-11, under 510(k) number K251992.

Who is the listed applicant for ArmSure Fluoroscopic Positioning System?

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

What is the FDA product code for ArmSure Fluoroscopic Positioning System?

The FDA product code for ArmSure Fluoroscopic Positioning System is OWB.

相關臨床試驗

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相關器械（代碼：OWB）

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。

K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.K261413EXTRON 3;EXTRON 6DRTECH CorporationK254205Zenition 30Philips Medical Systems Nederland B.V.K260607防護系統（西門子 30x40）Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, Inc.

官方來源

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