SCIVIEW SYSTEM, MODEL SC1250 AND PIXIE IMAGING SOF

System, Image Processing, Radiological

IMAGE SYSTEMS, INC.

The following data is part of a premarket notification filed by Image Systems, Inc. with the FDA for Sciview System, Model Sc1250 And Pixie Imaging Sof.

Pre-market Notification Details

Device IDK901422
510k NumberK901422
Device Name:SCIVIEW SYSTEM, MODEL SC1250 AND PIXIE IMAGING SOF
ClassificationSystem, Image Processing, Radiological
Applicant IMAGE SYSTEMS, INC. CONSULTANT 16303 PANORAMIC WAY San Leandro,  CA  94578
ContactJ Allsebrook
CorrespondentJ Allsebrook
IMAGE SYSTEMS, INC. CONSULTANT 16303 PANORAMIC WAY San Leandro,  CA  94578
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-03-26
Decision Date1990-08-21

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