MIE - GAMMA CAMERA SYSTEMS

System, Tomography, Computed, Emission

MIE AMERICA, INC.

The following data is part of a premarket notification filed by Mie America, Inc. with the FDA for Mie - Gamma Camera Systems.

Pre-market Notification Details

Device IDK053086
510k NumberK053086
Device Name:MIE - GAMMA CAMERA SYSTEMS
ClassificationSystem, Tomography, Computed, Emission
Applicant MIE AMERICA, INC. 420 BENNETT RD. Elk Grove Village,  IL  60007
ContactKay Warren
CorrespondentKay Warren
MIE AMERICA, INC. 420 BENNETT RD. Elk Grove Village,  IL  60007
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-11-02
Decision Date2006-01-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04260484140074 K053086 000
04260484140043 K053086 000

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