Preview Shoulder

Automated Radiological Image Processing Software

Genesis Software Innovations

The following data is part of a premarket notification filed by Genesis Software Innovations with the FDA for Preview Shoulder.

Pre-market Notification Details

Device IDK210556
510k NumberK210556
Device Name:Preview Shoulder
ClassificationAutomated Radiological Image Processing Software
Applicant Genesis Software Innovations 220 Lyon St NW Suite 500 Grand Rapids,  MI  49503
ContactMatt Miller
CorrespondentMatt Miller
Genesis Software Innovations 220 Lyon St NW Suite 500 Grand Rapids,  MI  49503
Product CodeQIH  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-25
Decision Date2021-04-21

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