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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 Triage And Notification Software
510(k) Number K182177
Device Name Accipiolx
Applicant
MaxQ-Al Ltd.
76 Yigal Alon Street, 5th Floor
Tel Aviv,  IL 6706701
Applicant Contact Joshua Schulman
Correspondent
MaxQ-Al Ltd.
76 Yigal Alon Street, 5th Floor
Tel Aviv,  IL 6706701
Correspondent Contact Joshua Schulman
Regulation Number892.2080
Classification Product Code
QAS  
Date Received08/10/2018
Decision Date 10/26/2018
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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