MODIFICATION TO MIRAGE

System, Image Processing, Radiological

SEGAMI CORP., INC.

The following data is part of a premarket notification filed by Segami Corp., Inc. with the FDA for Modification To Mirage.

Pre-market Notification Details

Device IDK010726
510k NumberK010726
Device Name:MODIFICATION TO MIRAGE
ClassificationSystem, Image Processing, Radiological
Applicant SEGAMI CORP., INC. 8335 GUILFORD RD. SUITE I Columbia,  MD  21046
ContactPhilippe A Briandet
CorrespondentPhilippe A Briandet
SEGAMI CORP., INC. 8335 GUILFORD RD. SUITE I Columbia,  MD  21046
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-03-12
Decision Date2001-04-26

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