QuantorView

System, Image Processing, Radiological

3DISC AMERICAS

The following data is part of a premarket notification filed by 3disc Americas with the FDA for Quantorview.

Pre-market Notification Details

Device IDK151687
510k NumberK151687
Device Name:QuantorView
ClassificationSystem, Image Processing, Radiological
Applicant 3DISC AMERICAS 22560 GLENN DR STE 116 Sterling,  VA  20164
ContactSigrid Smitt-jeppesen
CorrespondentDaniel Kamm
KAMM & ASSOCIATES 8870 RAVELLO CT Naples,  FL  34114
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-06-23
Decision Date2015-08-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08809466041112 K151687 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.