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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, image processing, radiological
510(k) Number K202229
Device Name AI Metrics
AI Metrics, LLC
432 Renaissance Dr.
Hoover,  AL  35226
Applicant Contact Andrew D. Smith
Innolitics, LLC
1101 West 34th St #550
Austin,  TX  78705
Correspondent Contact Yujan Shrestha
Regulation Number892.2050
Classification Product Code
Date Received08/07/2020
Decision Date 12/22/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No