PROGENY VANTAGE PANORAMIC X-RAY SYSTEM

System, X-ray, Extraoral Source, Digital

MIDMARK

The following data is part of a premarket notification filed by Midmark with the FDA for Progeny Vantage Panoramic X-ray System.

Pre-market Notification Details

Device IDK091866
510k NumberK091866
Device Name:PROGENY VANTAGE PANORAMIC X-RAY SYSTEM
ClassificationSystem, X-ray, Extraoral Source, Digital
Applicant MIDMARK 675 HEATHROW DR. Lincolnshire,  IL  60069
ContactAlan Krema
Product CodeMUH  
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2009-06-24
Decision Date2009-07-20
Summary:summary

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