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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 K252229
Device Name BELLIGER ACE
Applicant
Genoray Co., Ltd.
60, Dunchon-Daero 541beon-Gil,
Jungwon-Gu
Seongnam-Si,  CN 13212
Applicant Contact Dongwon Kang
Correspondent
Genoray America, Inc.
1220 N Simon Cir.
Unit B
Anaheim,  CA  92806
Correspondent Contact Simon Jo
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received07/16/2025
Decision Date 04/02/2026
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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