Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20

System, X-ray, Extraoral Source, Digital

RealCloud Imaging Inc. Dba RealCloud Imaging

The following data is part of a premarket notification filed by Realcloud Imaging Inc. Dba Realcloud Imaging with the FDA for Brasseler Gem, Brasseler Gem10, Brasseler Gem15, Brasseler Gem20.

Pre-market Notification Details

Device IDK221955
510k NumberK221955
Device Name:Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20
ClassificationSystem, X-ray, Extraoral Source, Digital
Applicant RealCloud Imaging Inc. Dba RealCloud Imaging 2625 North Loop Drive, Suite 2130 Ames,  IA  50010
ContactDouglas A Golay
CorrespondentEd Johansen
W. Edward Johansen 1239 Stanford Street, Apartment Number 205 Santa Monica,  CA  90404
Product CodeMUH  
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-05
Decision Date2022-08-31

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