InVisionOS

System, Image Processing, Radiological

PrecisionOS Technology Inc.

The following data is part of a premarket notification filed by Precisionos Technology Inc. with the FDA for Invisionos.

Pre-market Notification Details

Device IDK210344
510k NumberK210344
Device Name:InVisionOS
ClassificationSystem, Image Processing, Radiological
Applicant PrecisionOS Technology Inc. 500-319 West Hastings Street Vancouver,  CA V6b 1h6
ContactDanny Goel
CorrespondentDanny Goel
PrecisionOS Technology Inc. 500-319 West Hastings Street Vancouver,  CA V6b 1h6
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-05
Decision Date2021-11-10

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.