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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K233530
Device Name EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM)
Applicant
DRTECH Corporation
Suite #1, 2 Floor /Suite # 2, 3 Floor, 29
Dunchon-Daero 541 Beon-Gil, Jungwon-Gu
Seongnam-Si,  KR 13216
Applicant Contact Kim Hanbyul
Correspondent
DRTECH Corporation
Suite #1, 2 Floor /Suite # 2, 3 Floor, 29
Dunchon-Daero 541 Beon-Gil, Jungwon-Gu
Seongnam-Si,  KR 13216
Correspondent Contact Kim Hanbyul
Regulation Number892.1680
Classification Product Code
KPR  
Date Received11/02/2023
Decision Date 07/26/2024
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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