Rapid LVO

Radiological Computer-assisted Triage And Notification Software

ISchemaView Inc.

The following data is part of a premarket notification filed by Ischemaview Inc. with the FDA for Rapid Lvo.

Pre-market Notification Details

Device IDK200941
510k NumberK200941
Device Name:Rapid LVO
ClassificationRadiological Computer-assisted Triage And Notification Software
Applicant iSchemaView Inc. 433 Park Point Drive, Suite 220 Golden,  CO  80401
ContactJim Rosa
CorrespondentJim Rosa
iSchemaView Inc. 433 Park Point Drive, Suite 220 Golden,  CO  80401
Product CodeQAS  
CFR Regulation Number892.2080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-08
Decision Date2020-07-09

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