CLIO/CLIOSOFT

System, Image Processing, Radiological

SOTA PRECISION OPTICS, INC.

The following data is part of a premarket notification filed by Sota Precision Optics, Inc. with the FDA for Clio/cliosoft.

Pre-market Notification Details

Device IDK110886
510k NumberK110886
Device Name:CLIO/CLIOSOFT
ClassificationSystem, Image Processing, Radiological
Applicant SOTA PRECISION OPTICS, INC. 1073 NORTH BATAVIA ST. SUITE B Orange,  CA  92867
ContactBrian Kim
CorrespondentBrian Kim
SOTA PRECISION OPTICS, INC. 1073 NORTH BATAVIA ST. SUITE B Orange,  CA  92867
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-03-30
Decision Date2011-06-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00851159007026 K110886 000
00851159007019 K110886 000
00851159007002 K110886 000

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