AnatomicAligner

System, Image Processing, Radiological

The Methodist Hospital Research Institute D/b/a Houston

The following data is part of a premarket notification filed by The Methodist Hospital Research Institute D/b/a Houston with the FDA for Anatomicaligner.

Pre-market Notification Details

Device IDK190767
510k NumberK190767
Device Name:AnatomicAligner
ClassificationSystem, Image Processing, Radiological
Applicant The Methodist Hospital Research Institute D/b/a Houston Methodist Research Institute 6670 Bertner Avenue Houston,  TX  77030
ContactChristina Talley
CorrespondentChristina Talley
The Methodist Hospital Research Institute D/b/a Houston Methodist Research Institute 6670 Bertner Avenue Houston,  TX  77030
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-25
Decision Date2020-03-16

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