SIS System (Version 5.1.0)

System, Image Processing, Radiological

Surgical Information Sciences, Inc.

The following data is part of a premarket notification filed by Surgical Information Sciences, Inc. with the FDA for Sis System (version 5.1.0).

Pre-market Notification Details

Device IDK210071
510k NumberK210071
Device Name:SIS System (Version 5.1.0)
ClassificationSystem, Image Processing, Radiological
Applicant Surgical Information Sciences, Inc. 10405 6th Avenue N, Suite 110 Plymouth,  MN  55441
ContactAnn Quinlan-smith
CorrespondentKelliann H. Payne
Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia,  PA  19103
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-11
Decision Date2021-03-31

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