Simpleware ScanIP Medical

System, Image Processing, Radiological

Synopsys (Northern Europe) Ltd.

The following data is part of a premarket notification filed by Synopsys (northern Europe) Ltd. with the FDA for Simpleware Scanip Medical.

Pre-market Notification Details

Device IDK203195
510k NumberK203195
Device Name:Simpleware ScanIP Medical
ClassificationSystem, Image Processing, Radiological
Applicant Synopsys (Northern Europe) Ltd. Bradninch Hall, Castle Street Exeter,  GB Ex4 3pl
ContactJessica James
CorrespondentJessica James
Synopsys (Northern Europe) Ltd. Bradninch Hall, Castle Street Exeter,  GB Ex4 3pl
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-28
Decision Date2021-04-01

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