MiPACS HTML5 Web Viewer

System, Image Processing, Radiological

LEAD Technologies Inc.

The following data is part of a premarket notification filed by Lead Technologies Inc. with the FDA for Mipacs Html5 Web Viewer.

Pre-market Notification Details

Device IDK212984
510k NumberK212984
Device Name:MiPACS HTML5 Web Viewer
ClassificationSystem, Image Processing, Radiological
Applicant LEAD Technologies Inc. 1927 S. Tryon Street, Suite 200 Charlotte,  NC  28203
ContactWilliam Little
CorrespondentCarl Alletto
O Tech Inc. 8317 Belew Drive Mckinney,  TX  75071
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-17
Decision Date2021-11-12

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