XPLORER 1100

System, X-ray, Stationary

IMAGING DYNAMICS COMPANY LTD.

The following data is part of a premarket notification filed by Imaging Dynamics Company Ltd. with the FDA for Xplorer 1100.

Pre-market Notification Details

Device IDK062417
510k NumberK062417
Device Name:XPLORER 1100
ClassificationSystem, X-ray, Stationary
Applicant IMAGING DYNAMICS COMPANY LTD. 151,2340 PEGASUS WAY, NE Calgary, Alberta,  CA T2e 8m5
ContactShirantha Samarappuli
CorrespondentShirantha Samarappuli
IMAGING DYNAMICS COMPANY LTD. 151,2340 PEGASUS WAY, NE Calgary, Alberta,  CA T2e 8m5
Product CodeKPR  
Subsequent Product CodeIZZ
Subsequent Product CodeMQB
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-08-18
Decision Date2006-09-15

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