Critical Care Suite With Endotracheal Tube Positing AI Algorithm

Automated Radiological Image Processing Software

GE Medical Systems, LLC

The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Critical Care Suite With Endotracheal Tube Positing Ai Algorithm.

Pre-market Notification Details

Device IDK211161
510k NumberK211161
Device Name:Critical Care Suite With Endotracheal Tube Positing AI Algorithm
ClassificationAutomated Radiological Image Processing Software
Applicant GE Medical Systems, LLC 3000 N. Grandview Blvd Waukesha,  WI  53188
ContactChris Paulik
CorrespondentChris Paulik
GE Medical Systems, LLC 3000 N. Grandview Blvd Waukesha,  WI  53188
Product CodeQIH  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-19
Decision Date2021-10-29

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