System, Image Processing, Radiological

Ziosoft, Inc.

The following data is part of a premarket notification filed by Ziosoft, Inc. with the FDA for Ziostation2.

Pre-market Notification Details

Device IDK200315
510k NumberK200315
Device Name:Ziostation2
ClassificationSystem, Image Processing, Radiological
Applicant Ziosoft, Inc. MitaKokusai Bldg., 1-4-28 Mita Minato-ku,  JP 108-0073
ContactTsuyoshi Nagata
CorrespondentRichard Ball
Ziosoft USA Inc. 1301 Shoreway Road, Suite 325 Belmont,  CA  94002
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-07
Decision Date2020-05-05

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