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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 K183285
Device Name cmTriage
Applicant
CureMetrix, Inc
9404 Genesee Ave., Suite 330
La Jolla,  CA  92037
Applicant Contact Kevin Harris
Correspondent
CureMetrix, Inc
9404 Genesee Ave., Suite 330
La Jolla,  CA  92037
Correspondent Contact Kevin Harris
Regulation Number892.2080
Classification Product Code
QFM  
Date Received11/26/2018
Decision Date 03/08/2019
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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