MIM - SPECTRA Quant

System, Image Processing, Radiological

MIM Software Inc.

The following data is part of a premarket notification filed by Mim Software Inc. with the FDA for Mim - Spectra Quant.

Pre-market Notification Details

Device IDK180815
510k NumberK180815
Device Name:MIM - SPECTRA Quant
ClassificationSystem, Image Processing, Radiological
Applicant MIM Software Inc. 25800 Science Park Drive - Suite 180 Cleveland,  OH  44122
ContactLynn Hanigan
CorrespondentLynn Hanigan
MIM Software Inc. 25800 Science Park Drive - Suite 180 Cleveland,  OH  44122
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-29
Decision Date2018-06-22
Summary:summary

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