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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K251992
Device Name ArmSure Fluoroscopic Positioning System
Applicant
Savfe Co. , Ltd.
2f., #89, Qiaohe Rd.
Zhonghe Dist.,
New Taipei City,  TW 235030
Applicant Contact Hsiao Man Hsu
Correspondent
Savfe Co. , Ltd.
2f., #89, Qiaohe Rd.
Zhonghe Dist.,
New Taipei City,  TW 235030
Correspondent Contact Hsiao Man Hsu
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   LLZ  
Date Received06/27/2025
Decision Date 02/11/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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