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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K232367
Device Name cmAngio® V1.0
Applicant
CureMetrix, Inc.
402 West Broadway
Suite # 400
San Diego,  CA  92101
Applicant Contact Kevin Harris
Correspondent
CureMetrix, Inc.
402 West Broadway
Suite# 400
San Diego,  CA  92101
Correspondent Contact Rekha Anand
Regulation Number892.2050
Classification Product Code
QIH  
Date Received08/08/2023
Decision Date 10/05/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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