Ezra Plexo Software

Automated Radiological Image Processing Software

Ezra AI Inc.

The following data is part of a premarket notification filed by Ezra Ai Inc. with the FDA for Ezra Plexo Software.

Pre-market Notification Details

Device IDK192969
510k NumberK192969
Device Name:Ezra Plexo Software
ClassificationAutomated Radiological Image Processing Software
Applicant Ezra AI Inc. 79 Madison Ave., Ste 545 New York,  NY  10016
ContactDavid Girard
CorrespondentDavid Girard
Ezra AI Inc. 79 Madison Ave., Ste 545 New York,  NY  10016
Product CodeQIH  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-23
Decision Date2020-07-10

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.