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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
CureMetrix, Inc.
402 West Broadway
Suite # 400
San Diego,  CA  92101
Applicant Contact Kevin Harris
CureMetrix, Inc.
402 West Broadway
Suite# 400
San Diego,  CA  92101
Correspondent Contact Rekha Anand
Regulation Number892.2050
Classification Product Code
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