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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Computer-Assisted Prioritization Software For Lesions
510(k) Number K193300
Device Name AIMI-Triage CXR PTX
Applicant
Radlogics, Inc.
24 Westland Ave., #28
Boston,  MA  02115
Applicant Contact Moshe Becker
Correspondent
Hogan Lovells U.S. Lpp
555 13th St. NW
Washington,  DC  20004
Correspondent Contact John J. Smith
Regulation Number892.2080
Classification Product Code
QFM  
Date Received11/27/2019
Decision Date 04/08/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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