Rapid ASPECTS

Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer

ISchemaView Inc.

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

Pre-market Notification Details

Device IDK200760
510k NumberK200760
Device Name:Rapid ASPECTS
ClassificationComputer-assisted Diagnostic Software For Lesions Suspicious For Cancer
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 CodePOK  
CFR Regulation Number892.2060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-24
Decision Date2020-06-26

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