Synapse PACS

System, Image Processing, Radiological

FUJIFILM MEDICAL SYSTEMS U.S.A., INC.

The following data is part of a premarket notification filed by Fujifilm Medical Systems U.s.a., Inc. with the FDA for Synapse Pacs.

Pre-market Notification Details

Device IDK160108
510k NumberK160108
Device Name:Synapse PACS
ClassificationSystem, Image Processing, Radiological
Applicant FUJIFILM MEDICAL SYSTEMS U.S.A., INC. 419 WEST AVENUE Stamford,  CT  06902
ContactJyh-shyan Lin
CorrespondentJyh-shyan Lin
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. 419 WEST AVENUE Stamford,  CT  06902
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-01-19
Decision Date2016-02-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00854904006008 K160108 000

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