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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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