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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K181892
Device Name Ziostation2
Applicant
Ziosoft, Inc.
MitaKokusai Bldg., 1-4-28 Mita
Minato-ku,  JP 108-0073
Applicant Contact Tsuyoshi Nagata
Correspondent
Ziosoft USA Inc.
1301 Shoreway Road, Suite 325
Belmont,  CA  94002
Correspondent Contact Richard Ball
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Codes
JAK   LNH  
Date Received07/13/2018
Decision Date 10/09/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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