MAMEX DC MG11

System, X-ray, Mammographic

ORION CORP.

The following data is part of a premarket notification filed by Orion Corp. with the FDA for Mamex Dc Mg11.

Pre-market Notification Details

Device IDK881505
510k NumberK881505
Device Name:MAMEX DC MG11
ClassificationSystem, X-ray, Mammographic
Applicant ORION CORP. 3 WILLOW RIDGE CIRCLE Conroe,  TX  77304
ContactJohn R Hogan
CorrespondentJohn R Hogan
ORION CORP. 3 WILLOW RIDGE CIRCLE Conroe,  TX  77304
Product CodeIZH  
CFR Regulation Number892.1710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-04-11
Decision Date1988-06-10

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