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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 K201310
Device Name Accipiolx
Applicant
MaxQ Al Ltd.
96 Yigal Alon Street, 1st Floor
tel aviv,  IL 6789140
Applicant Contact joshua schulman
Correspondent
MaxQ Al Ltd.
96 Yigal Alon Street, 1st Floor
tel aviv,  IL 6789140
Correspondent Contact joshua schulman
Regulation Number892.2080
Classification Product Code
QAS  
Date Received05/15/2020
Decision Date 08/07/2020
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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