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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
Ziosoft, Inc.
MitaKokusai Bldg., 1-4-28 Mita
Minato-ku,  JP 108-0073
Applicant Contact Tsuyoshi Nagata
Ziosoft USA Inc.
1301 Shoreway Road, Suite 325
Belmont,  CA  94002
Correspondent Contact Richard Ball
Regulation Number892.2050
Classification Product Code
Subsequent Product Codes
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