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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 Avenue, #28
Boston,  MA  02115
Applicant Contact Moshe Becker
Correspondent
Hogan Lovells US LPP
555 13th Street 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
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